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Maturitas 62 (2009) 58–65 Contents lists available at ScienceDirect Maturitas journal homepage: www.elsevier.com/locate/maturitas Changes in body composition following a dietary and lifestyle intervention trial: The postmenopausal health study Yannis Manios , George Moschonis, Konstantinos Koutsikas, Stalo Papoutsou, Ioanna Petraki, Elena Bellou, Anthi Naoumi, Sofia Kostea, Sofia Tanagra Department of Nutrition and Dietetics, Harokopio University, 70, El.Venizelou Ave, 176 71 Kallithea, Athens, Greece article info Article history: Received 24 April 2008 Received in revised form 4 November 2008 Accepted 14 November 2008 Keywords: Body fat mass Dairy products Calcium Nutrition education abstract Objective: To examine whether dietary changes and the consumption of dairy products fortified with calcium and vitamin D 3 versus the use of a calcium supplement alone could have any effect on anthro- pometric and body composition indices of postmenopausal women over a 12-month period. Methods: 101 healthy postmenopausal women were randomized to a dietary intervention group (DG: n = 39), receiving approximately 1200 mg of calcium and 7.5 g of vitamin D 3 per day via fortified dairy products and attending biweekly dietary and lifestyle intervention sessions; a calcium supplemented group (CaG: n = 26) receiving a total of 1200 mg calcium per day; and a control group who continued with their usual diet (CG: n = 36). Dietary, physical activity, anthropometric, body composition and distribution (based on DXA) data were collected at baseline and after 12 months of intervention. Results: No significant differences were observed in the mean 12-month changes in certain anthropomet- ric (i.e. weight, BMI) and DXA (i.e. total body fat and lean mass) indices between groups. However, the DG was found to have a lower decrease in mid-arm muscle circumference (P < 0.001) and a lower increase in the sum of skinfolds’ thickness (P = 0.042) compared with the CaG and the CG. Furthermore, the DG was also found to have a greater decrease in the percentage of legs’ fat mass (P = 0.025) and a higher increase in the percentage of legs’ lean mass (P =0.012) compared with the two other groups. Conclusion: The application of a holistic intervention approach combining nutrition and lifestyle coun- seling with consumption of fortified dairy products for 12 months was found to have favourable changes in certain anthropometric and body composition indices compared to calcium supplementation alone. © 2008 Elsevier Ireland Ltd. All rights reserved. 1. Introduction Obesity and its health complications constitute the most fre- quent nutrition-related conditions affecting a wide range of populations globally [1]. Regarding the investigation of the under- lying causes of obesity most studies so far have mainly focused on the effects of energy and macronutrients’ intake on weight regulation, while less attention has been given to the role of micronutrients [2]. It has been proposed by recent literature that among minerals, calcium intake in particular, might play an important role in weight management [3]. Results from several epidemiological cross-sectional studies have shown an inverse association between dietary calcium intake and dairy consump- tion with adiposity indices [4–7]. Using animal and cellular models Zemel and co-workers introduced a possible biological mecha- nism to support these epidemiological associations, showing that Corresponding author. Tel.: +30 210 9549156; fax: +30 210 9549141. E-mail address: [email protected] (Y. Manios). increased levels of parathyroid hormone and 1,25 dihydroxyvitamin D induced by low dietary calcium intake can lead to an increase of intracellular calcium, which serves as a second messenger to stimulate lipogenesis, inhibit lipolysis and reduce thermogenesis [8]. Although the findings of epidemiological studies are promising, still only intervention studies can shed light to these associations. The results from randomized controlled intervention trials con- ducted with humans to examine the role of calcium intake on weight regulation are controversial. Regarding studies examining the effect of increased calcium intake via supplementation, most showed no differences in the changes in body weight or body composition between treatment arms in both adults and children [9–14]. Regarding studies examining the effect of increased cal- cium intake via dairy products on body composition, several of those did not detect any group differences with respect to the changes in anthropometric and total body composition indices [15–18]. Nonetheless in two randomized controlled trials energy restriction resulted to a greater weight and fat mass loss and to a lower decrease of lean body mass in obese adults having increased 0378-5122/$ – see front matter © 2008 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2008.11.005
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Page 1: Changes in body composition following a dietary and lifestyle intervention trial: The postmenopausal health study

Maturitas 62 (2009) 58–65

Contents lists available at ScienceDirect

Maturitas

journa l homepage: www.e lsev ier .com/ locate /matur i tas

Changes in body composition following a dietary and lifestyle interventiontrial: The postmenopausal health study

Yannis Manios ∗, George Moschonis, Konstantinos Koutsikas, Stalo Papoutsou,Ioanna Petraki, Elena Bellou, Anthi Naoumi, Sofia Kostea, Sofia TanagraDepartment of Nutrition and Dietetics, Harokopio University, 70, El.Venizelou Ave, 176 71 Kallithea, Athens, Greece

a r t i c l e i n f o

Article history:Received 24 April 2008Received in revised form 4 November 2008Accepted 14 November 2008

Keywords:Body fat massDairy productsCalciumNutrition education

a b s t r a c t

Objective: To examine whether dietary changes and the consumption of dairy products fortified withcalcium and vitamin D3 versus the use of a calcium supplement alone could have any effect on anthro-pometric and body composition indices of postmenopausal women over a 12-month period.Methods: 101 healthy postmenopausal women were randomized to a dietary intervention group (DG:n = 39), receiving approximately 1200 mg of calcium and 7.5 �g of vitamin D3 per day via fortified dairyproducts and attending biweekly dietary and lifestyle intervention sessions; a calcium supplementedgroup (CaG: n = 26) receiving a total of 1200 mg calcium per day; and a control group who continued withtheir usual diet (CG: n = 36). Dietary, physical activity, anthropometric, body composition and distribution(based on DXA) data were collected at baseline and after 12 months of intervention.Results: No significant differences were observed in the mean 12-month changes in certain anthropomet-ric (i.e. weight, BMI) and DXA (i.e. total body fat and lean mass) indices between groups. However, the DGwas found to have a lower decrease in mid-arm muscle circumference (P < 0.001) and a lower increase inthe sum of skinfolds’ thickness (P = 0.042) compared with the CaG and the CG. Furthermore, the DG wasalso found to have a greater decrease in the percentage of legs’ fat mass (P = 0.025) and a higher increasein the percentage of legs’ lean mass (P = 0.012) compared with the two other groups.

Conclusion: The application of a holistic intervention approach combining nutrition and lifestyle coun-seling with consumption of fortified dairy products for 12 months was found to have favourablechanges in certain anthropometric and body composition indices compared to calcium supplementation

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. Introduction

Obesity and its health complications constitute the most fre-uent nutrition-related conditions affecting a wide range ofopulations globally [1]. Regarding the investigation of the under-

ying causes of obesity most studies so far have mainly focusedn the effects of energy and macronutrients’ intake on weightegulation, while less attention has been given to the role oficronutrients [2]. It has been proposed by recent literature

hat among minerals, calcium intake in particular, might play anmportant role in weight management [3]. Results from severalpidemiological cross-sectional studies have shown an inverse

ssociation between dietary calcium intake and dairy consump-ion with adiposity indices [4–7]. Using animal and cellular modelsemel and co-workers introduced a possible biological mecha-ism to support these epidemiological associations, showing that

∗ Corresponding author. Tel.: +30 210 9549156; fax: +30 210 9549141.E-mail address: [email protected] (Y. Manios).

378-5122/$ – see front matter © 2008 Elsevier Ireland Ltd. All rights reserved.oi:10.1016/j.maturitas.2008.11.005

© 2008 Elsevier Ireland Ltd. All rights reserved.

increased levels of parathyroid hormone and 1,25 dihydroxyvitaminD induced by low dietary calcium intake can lead to an increaseof intracellular calcium, which serves as a second messenger tostimulate lipogenesis, inhibit lipolysis and reduce thermogenesis[8].

Although the findings of epidemiological studies are promising,still only intervention studies can shed light to these associations.The results from randomized controlled intervention trials con-ducted with humans to examine the role of calcium intake onweight regulation are controversial. Regarding studies examiningthe effect of increased calcium intake via supplementation, mostshowed no differences in the changes in body weight or bodycomposition between treatment arms in both adults and children[9–14]. Regarding studies examining the effect of increased cal-cium intake via dairy products on body composition, several of

those did not detect any group differences with respect to thechanges in anthropometric and total body composition indices[15–18]. Nonetheless in two randomized controlled trials energyrestriction resulted to a greater weight and fat mass loss and to alower decrease of lean body mass in obese adults having increased
Page 2: Changes in body composition following a dietary and lifestyle intervention trial: The postmenopausal health study

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alcium intake from dairy products compared with calcium sup-lemented and control subjects [19,20].

Due to this contradicting findings and the ongoing enlargementf the obesity epidemic problem, there is a critical need for a betternderstanding of the effect of increased calcium intake either viaairy products or supplements on body weight and body compo-ition. Regarding body composition no study so far has examinedhanges in segmental body parts, such as in the arms, legs and trunk.he aim of the current study was to examine whether supplementa-ion of calcium or dairy products enriched with calcium and vitamin3 in postmenopausal women for 12 months could have any effectn several anthropometric and body composition indices. Theseata represent a secondary analysis of the Postmenopausal Healthtudy, which was initially designed to assess changes in bone massnd biochemical indices of bone metabolism.

. Methods

.1. Sampling

.1.1. First screeningThe study was initiated in July 2004 with the approval of the

thical Committee of Harokopio University of Athens. Volunteers’ecruitment was conducted during July 2004 via informationalrochures and posters distributed in public buildings and com-unity centers in three municipalities within the wider district

f Athens, namely Nea Smyrni, Kallithea and Neo Iraklio. Throughhis open invitation conducted at a community level and withhe co-operation of the local authorities, a sample of 307 Greekostmenopausal women registered voluntarily to participate inhe first screening of the study. The first screening comprised

short questionnaire that was specifically designed to gathernformation on women’s medical history, demographic data (i.e.ducational level, marital status, etc.), dietary, physical activitynd smoking habits. Furthermore, bone status of all volunteersas assessed using calcaneal quantitative ultrasound (QUS) mea-

urement, carried out by the SAHARA Clinical Bone Sonometer21]. Through this initial screening those women diagnosed hav-ng a T-score lower than −2.5, taking medications (i.e. thiazideiuretics, glucocorticoids) and/or dietary supplements (calcium,agnesium, phosphate or vitamin D) that affect bone metabolism,

aving any kind of bone-degenerative chronic disease (i.e. diabetes,ephrolithiasis, heart disease, cancer, hyper- and hypothyroidism,yperparathyroidism, impaired renal and liver function), smokingnd being at menopause for less than 1 year were excluded fromhe second screening of the study.

.1.2. Second screeningAfter the initial screening 134 women (age 55–65 years)

atisfying the inclusion criteria were identified and werenvited to participate at the second screening of the studySeptember–October 2004). During the second screening all volun-eers underwent a dual-energy X-ray absorptiometry (DXA; LunarPX-MD, Madison, USA) measurement, as well as haematologicalnd biochemical examinations comprising haematological profile,rythrocyte sedimentation rate and serum calcium, phosphorus,lutamic-oxaloacetic and glutamic-pyruvic transaminases, alkalinehosphatase and creatinine levels. Those women found to be osteo-orotic, according to the data provided by the DXA examination, oraving abnormal values on the aforementioned blood indices, were

xcluded from the study. This second screening yielded 112 eligi-le women who prior to their entry to the study signed detailedonsent-forms of participation and proceeded in the interventiontudy. The intervention component of the study was initiated inctober 2004.

s 62 (2009) 58–65 59

2.1.3. Study groupsThese 112 eligible women were randomly assigned to three

groups, a “Dietary and Lifestyle Intervention Group” (DG), a“Calcium-supplemented Group” (CaG) and a “Control Group” (CG).The DG consisted of 42 women, who were provided and encouragedto consume on a daily basis three portions of low fat dairy productsfortified with calcium and vitamin D3 (one portion equals to 250 mlof milk and to 200 g of yoghurt). The dairy products, produced byFriesland Foods Hellas were milk and yoghurt enriched with cal-cium (33%), providing a total of 400 mg of calcium per portion.The extra calcium source was milk protein concentrated, a naturalsource of milk calcium. Milk’s protein content was 12.5 g per por-tion while yoghurt’s protein content was 15 g per portion. Regardingvitamin D each portion provided 2.5 �g of vitamin D3. To ensurecompliance to the intervention scheme “Health and Nutrition Edu-cation” sessions were held biweekly within the settings of the Uni-versity. During these sessions subjects were also provided with theappropriate number of dairy products for the next two weeks. Theaim of the sessions delivered to the DG was to increase awarenessof the subjects on health issues, primarily related to osteoporosis,but also to motivate them to change certain lifestyle and dietaryhabits in order to improve their health status. The first sessions pri-marily focused on educating the subjects on the pathophysiologyof osteoporosis as well as the risk factors (health related behaviors)related to the development of the disease. Gradually the sessionsbecame more interactive and emphasis was given in guiding andassisting the subjects in changing their dietary habits according tothe Mediterranean diet profile [22]. In order to assess complianceto the instructions given at the educational sessions, subjects inthe DG were periodically provided with food and physical activityrecords, where they were instructed to record the frequency andportions of fruits, vegetables and dairy products consumed as wellas the time spent daily to recreational moderate-to-vigorous phys-ical activities for a 2-week period. These records were checked bymembers of the research team and discussed with the DG subjectsat the next meeting-session. Furthermore, in order to avoid excesscaloric intake subjects in the DG were also advised to substituteother dairy products in their diet with those provided, while thenew dietary scheme that they were advised to follow was efficientin providing the recommended daily intake of calcium and vitaminD (about 1200 mg of calcium and 7.5 �g of vitamin D per day).

The CaG consisted of 30 women, who received an extra amountof 600 mg of supplementary calcium per day (87% of calcium lactategluconate and 13% of calcium carbonate) in the form of water-soluble tablets. This extra quantity was added to the estimateddietary calcium intake aiming to a minimum of 1200 mg/day. Sup-plements were provided to the subjects via home delivery on amonthly basis. Adherence to the supplement use was establishedby checking for remaining tablets in the returned packages from theprevious home delivery but also via weekly phone calls. Finally theCG consisted of 40 women, to whom no dietary intervention wasdelivered as they continued with their usual diet, which remainedlow in dietary calcium intake and dairy products consumptionthroughout the intervention period [22]. All three study groupswere given the results of medical examination and DXA analy-sis during scheduled meetings at the University right after everyscreening phase. The procedures followed during these meetingswere standard for all groups, including explanation of the results,simple dietary and lifestyle advice and discussion sessions. Fig. 1illustrates the entire sampling procedure followed in the presentstudy.

2.1.4. Assessment of the effectiveness of the intervention:outcomes evaluation

During the intervention period the subjects from all studygroups were invited to go through certain interviews and examina-

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60 Y. Manios et al. / Maturitas 62 (2009) 58–65

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ions primarily focusing on the assessment of the main outcomes ofhe present study, such as behavioral (i.e. dietary and physical activ-ty), anthropometric and clinical (i.e. body composition) indices.he data obtained from the second screening of the study weresed as baseline data. A final screening took place after 12 monthsf intervention at September/October 2005. At baseline and finalxamination the following study’s outcomes were evaluated.

.1.5. Dietary indicesAt baseline and final examinations the 24-h recall technique was

sed to collect dietary intake information for a total of 3 days, 2eekdays and 1 weekend day, most preferably Sunday. These dataere obtained during scheduled interviews with the study partici-ants at the University. All interviewers were rigorously trained toinimize interviewer effects. Respondents were asked to recall the

ype and amount of any food and beverage consumed during therevious day in a chronological order, i.e. from the time they wokep in the morning to the same time the following day. To improveccuracy of food descriptions and portion sizes, standard house-old measures (cups, tablespoons, etc.) and picture food modelsDairy Food Council, USA) were used during interviews to define

mounts when appropriate. Food intake data were analyzed usinghe Nutritionist V diet analysis software (First Databank, San Bruno,A), which was extensively amended to include Food Compositionables for Greek foods and recipes [23,24] and chemically analyzedommercial food items widely consumed in Greece. More infor-

xcluded and screened subjects.

mation on the procedures followed to estimate daily energy andnutrients’ intake is presented elsewhere [22].

2.1.6. Physical activity indicesAssessment of physical activity was made by a 3-day activ-

ity interview questionnaire. Respondents reported the time spenton various physical activities during 2 consecutive weekdays and1 weekend day. The questionnaire classified all work, sport, andleisure activities into four categories, on the basis of their averageintensity relative to the impact on the cardiovascular system (low tohigh), and also by subgrouping activities according to their impacton bone mass (low to high) [25]. The aim of the questionnairewas to determine the frequency and duration (hours per session)subjects devoted weekly in these physical activity categories. Thetotal amount of time devoted weekly on activity categories hav-ing intensity higher than 4 metabolic equivalents was defined astime spent on moderate-to-vigorous physical activities. Similarly,the time devoted weekly in activity categories having intensitylower than 2 metabolic equivalents was defined as time spent onsedentary activities.

2.1.7. Anthropometric measurementsAnthropometry was carried out during the initial screening, as

well as at baseline and follow-up examinations. In all the aforemen-tioned time points body weight and standing height were measuredin light clothing and with no shoes using a digital scale (Seca)

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Y. Manios et al. / Maturitas 62 (2009) 58–65 61

Table 1Baseline descriptive characteristics presented by group.

Dairy intervention group (n = 39) Control group (n = 36) Calcium supplemented group (n = 26) P-valueb

Mean (S.D.) Mean (S.D.) Mean (S.D.)

Age (years) 60.5 (4.4) 61.4 (5.1) 62.4 (9.5) 0.087Years since menopause 9.25 (5.9) 10.4 (6.67) 11.4 (11.5) 0.210Height (cm) 158.9 (6.7) 156.9 (5.9) 155.1 (7.9) 0.130MVPAa (min/week) 136.1 (153.0) 109.4 (154.8) 124.5 (246.8) 0.756

Educational levelLess than 9 years (%) 53.8 62.2 58.3 0.6519–12 years (%) 28.2 23.9 26.7More than 12 years (%) 17.9 13.9 15.0

Marital statusMarried (%)Single/divorced/widows (%) 35.9 30.6 38.3

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a Moderate-to vigorous physical activities.b P-values were derived from one way analysis of variance for normally distributessociations between categorical variables were tested by the Chi-square analysis.

ith an accuracy of ±100 g and a commercial stadiometer (Leices-er Height Measure) to the nearest 0.5 cm, respectively. Body massndex (BMI) was calculated as weight (kg) divided by height squaredm2). Left triceps, biceps, subscapular and suprailiac skinfold thick-ess, were measured with a Lange skinfold calliper. The sum ofhese four skinfolds was also estimated. Midarm muscle circum-erence (MAMC), an index of the body’s total skeletal muscle mass,as derived from the following equation: MAMC (cm) = left arm cir-

umference − [0.314 × triceps skinfold thickness (mm)] [26]. Waistircumference was measured at the level of umbilicus and hip cir-umference at the level of greater trochanters and pubic symphisiso the nearest 0.1 cm.

.1.8. Body composition indicesBody composition indices (i.e. total and segmental lean and fat

ass) were measured at baseline and at the final examination by

ual-energy X-ray absorptiometry (DXA; Lunar DPX-MD, Madison,SA) with the analysis software version 4.6. A daily quality assur-nce check was performed using a calibration standard of knownomposition, provided by the manufacturer. The scans were per-ormed in the morning by an experienced technician.

able 2hanges in dietary and biochemical indices.

Baseline mean (S.D.) 12 months mean (

nergy intake (kJ/day)Control group 7159.9 (1330.2) 6558.8 (1341.0)Calcium supplemented group 6715.6 (1907.5) 6440.9 (1922.8)Dairy intervention group 6815.8 (1348.3) 6672.8 (1359.5)P-value† 0.437 0.852

rotein intake (g/day)Control group 55.3 (15.3) 54.0 (15.8)a

Calcium supplemented group 57.6 (9.9) 50.5 (17.4)b

Dairy intervention group 51.8 (10.8) 64.1 (12.5)a,b

P-value† 0.413 0.002

alcium Intake (mg/day)Control group 712.7 (247.7) 723.7 (383.2)a,c

Calcium supplemented group 638.6 (262.2) 1147.4 (273.4)c

Dairy intervention group 687.2 (270.2) 1135.6 (281.7)a

P-value† 0.668 <0.001

itamin D (�g/day)Control group 0.59 (0.57) 1.00 (1.99)a

Calcium supplemented group 0.52 (0.22) 0.44 (0.58)b

Dairy intervention group 0.67 (1.06) 5.21 (1.89)a,b

P-value† 0.472 <0.001

he statistical analysis performed was repeated measures analysis of variance controllingetters indicate between-groups’ differences derived by post hoc multiple comparisons usis. control group. bP < 0.05 dairy intervention vs. calcium supplemented group.† Comparison among groups at baseline, 5 and 12 months, respectively (treatment effe

tinuous variables and the Kruskal–Wallis non-parametric test in the case of MVPA.

2.1.9. Statistical analysisThe sample sizes in the 3 groups were adequate since we

achieved statistical power greater than 90% for standardized dif-ferences between groups greater than 5% at probability of Type-Ierror < 0.05. The mean age of these women was 60.5 (S.E. 5.1) years(age range 55–65 years) and the average elapsed time since theirmenopause was 9.5 (S.E. 5.6) years. All data are reported as mean(standard deviation: S.D.) and as mean change over baseline (95%confidence interval: C.I.). The Kolmogorov–Smirnov test was usedto determine normality of distribution of the examined variables.Differences in baseline characteristics among the three groups ofwomen were evaluated with one-way analysis of variance and withthe Kruskal–Wallis test for normally and non-normally distributedvariables, respectively. The Chi-square test was used to evaluatethe significance of the associations between categorical variables.Repeated measures analysis of variance controlling for age was used

to evaluate the significance of the differences among groups atbaseline and at the end of the 12-month intervention (treatmenteffect); the significance of the changes observed within each group(time effect); and the effect of treatment × time interaction. In thecase of anthropometric and body composition indices the analyses

S.D.) 12-month change mean change (95% C.I.) Treatment × time*

0.362−601.1 (−1058.9 to −143.3)−275.0 (−1128.8 to 415.9)−143.0 (−588.9 to 302.9)

0.001−1.2 (−7.1 to 4.6)−7.1 (−11.3 to 0.8)12.3 (6.6–18.0)

<0.00111.0 (−103.7 to 125.7)

462.7 (266.8–658.6)448.4 (339.7–557.1)

<0.0010.41 (−0.51 to 1.33)

−0.08 (−0.93 to 0.77)4.54 (3.83–5.01)

for age of the study participants. *Treatment × time interaction effect. Superscriptng Bonferroni rule, correct the inflation in Type-I error: aP < 0.05 dairy intervention

ct).

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ere also controlled for energy intake and physical activity levels.he between-group factor was the study groups (i.e. DG vs. CG vs.aG); the within-group factor was the time-point of measurement.ll P-values reported were two-tailed. Statistical analysis was con-ucted with the SPSS statistical software (version 13.0). The levelf statistical significance was set at P ≤ 0.05.

. Results

Eleven of the 112 women initially assigned to participate in thetudy could not be re-examined at follow-up. The exact reasons ofropping out of the study are presented with more details else-here [22]. Consequently the number of subjects in each groupith full baseline and follow-up data were 39 in the DG, 36 in theG and 26 in the CaG. The baseline characteristics of the 101 studyarticipants with full data at baseline and follow-up examinationsre summarized in Table 1. No differences were observed in theseaseline characteristics among groups, indicating homogeneity inertain socio-demographic (i.e. age, years since menopause, edu-ational level and marital status), anthropometric (i.e. height) andifestyle (i.e. time spent to MVPA) characteristics.

Table 2 presents the values of certain dietary indices at baselinend at 12 months of intervention. Regarding dietary indices signifi-ant treatment × time interaction effects were observed for proteinnd vitamin D intakes (P ≤ 0.001), showing significant increases inhese variables only in the DG. Similarly a significant increase wasound for calcium intake both for the DG and the CaG (P < 0.001).

ithin group a significant decrease was observed for the CG withespect to their energy intake (−601.31; 95% C.I.: −1058.39 to143.2 kJ/day).

Table 3 displays the changes observed in several anthropometricndices of body composition. Significant treatment × time inter-ction effects were observed for MAMC (P < 0.001) and sum ofkinfolds’ thickness (P = 0.042). Specifically the decrease observedn MAMC was found to be lower in the DG than the decreases inhe other two groups. Furthermore, the increase observed in sumf skinfolds was found to be lower in the DG compared with thencreases in the CG and the CaG.

Tables 4 and 5 summarize the changes observed in the percent-ges of fat and lean body mass (total and segmental). Significantreatment × time interaction effects were observed only for legs’at mass (P = 0.025) and legs’ lean mass (P = 0.012). Precisely, thereas a significant decrease observed in the percent of legs’ fat mass

n the DG that was significantly greater than the changes observedn the two other groups. On the other hand the percent of legs’ lean

ass increased significantly only in the DG and this increase wasignificantly higher compared to the changes in the CG and the CaG.

. Discussion

The present study represents a secondary analysis of the Post-enopausal Health Study, a randomised controlled intervention

rial conducted with free-living healthy postmenopausal women inrder to examine the effect of calcium supplementation or dietaryntervention combining consumption of fortified dairy products

ith nutrition education on bone mass. The main findings of theurrent analysis were some more favourable changes in certainnthropometric and body composition indices, such as MAMC, sumf skinfolds, legs’ fat and legs’ lean body mass for the DG sub-ects compared with subjects in the two other groups (i.e. the CGnd the CaG) (Tables 3–5). On the contrary calcium supplemen-

ation alone was not found to induce any favourable changes onoth anthropometric and body composition indices, although meanalcium intake improved significantly in the CaG reaching the rec-mmended adequate intake level (1200 mg/day) [27]. The increasen the consumption of the fortified dairy products also induced the

s 62 (2009) 58–65

significantly higher intakes of protein and vitamin D observed inthe DG compared with the CG and the CaG (Table 2).

The findings of the current study regarding the effect of cal-cium supplementation on body weight and body composition are inline with the majority of studies conducted with postmenopausalwomen showing no significant differences between interventionand control subjects in body weight, BMI, total body fat and leanmass changes [3,11,13,28–31]. In all these studies the levels ofcalcium intake were ranging from 1000 to 1200 mg/day and theduration of the intervention was ranging from 3 to 24 months. Inaddition to these findings the present study showed no significantimpact of calcium supplementation on the changes observed inother anthropometric (i.e. MAMC, sum of skinfolds, hip circum-ference) and body composition indices of fat and lean mass inspecific body parts (i.e. arms, trunk and legs). Contrary to thesefindings there is only one previous study reporting a greater weightloss in postmenopausal women who were supplemented with1200 mg/day of calcium for a period of 4.3 years [32]. More recentdata from the Women’s Health Initiative clinical trial showed thatsupplementation of 1000 mg/day of calcium plus 10 �g/day of vita-min D to postmenopausal women during a 7-year interventionperiod had a small but significant favourable effect on preventingweight gain, primarily in women that had a low dietary calciumintake at baseline [33]. It could be hypothesized that the positiveeffect observed in these last two trials could be attributed to thecombination of calcium with vitamin D administration and to thelonger duration of the intervention, compared with all previousstudies that showed no significant effect of calcium supplementa-tion on body composition. However, in a previous systemic reviewit was suggested that among other factors (i.e. age, relative weight,ethnicity and sample size) the amount and type of calcium admin-istered, the duration of the study and the levels of habitual calciumintake at baseline do not appear to provide an explanation for thesecontradicting findings [3]. In any case further research is neededto clarify the exact conditions under which calcium supplemen-tation may exert a significant effect on anthropometric and bodycomposition indices.

Similar to most calcium supplementation studies the findingsfrom several intervention studies that used dairy products to induceincreases in calcium intake of postmenopausal women showed nosignificant differences regarding the changes in body weight, BMI,total body fat and lean mass between the dairy and control groups[3,16,31,34]. Up to a certain extent these findings are in accordancewith those reported by the present study, as no significant effectof dairy supplementation was observed for the changes in certainanthropometric (i.e. BMI, body weight, waist and hip circumfer-ences) and body composition indices (i.e. arms, trunk and totalbody fat and lean mass). However, two other studies conductedwith postmenopausal women reported significantly higher weightgains in the milk supplemented compared with the control groups[3,35]. Whether or not the increase in the consumption of dairyproducts will eventually lead to weight gain primarily depends onthe ability of subjects to regulate their energy intake by compensat-ing for the additional energy content provided by the dairy products[3]. In those studies not reporting weight or fat gains this com-pensation seems to have been achieved since energy intake wasnot found to differ between the dairy and control group. Similarlyin the present study there were no significant differences amonggroups with respect to energy intake at both baseline and follow-up examinations and despite the fact that subjects in the DG wereprovided with three extra portions of dairy products. This is prob-

ably indicative of the effectiveness of the ‘Health and NutritionEducation’ component of the intervention programme in increas-ing the self-efficacy of subjects in the DG to comply with the dietaryinstructions and to compensate for the additional energy derivedfrom the dairy servings provided to them. On the other hand in the
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Y. Manios et al. / Maturitas 62 (2009) 58–65 63

Table 3Changes in anthropometric indices of fat and lean body mass.

Baseline mean (S.D.) 12-month mean (S.D.) 12-month change mean change (95% C.I.) Treatment × time*

Body weight (kg) 0.119Control group 74.4 (12.2) 73.7 (13.9) −0.7 (−2.1 to 0.8)Calcium supplemented group 72.3 (7.6) 73.2 (8.6) 0.9 (−1.5 to 3.3)Dairy intervention group 71.2 (9.4) 72.7 (10.7) 1.4 (−0.6 to 2.9)P-value† 0.689 0.999

Body mass index (kg/m2) 0.255Control group 30.5 (5.3) 30.4 (6.5) −0.1 (−0.8 to 0.5)Calcium supplemented group 30.4 (6.1) 30.7 (7.6) 0.3 (−0.9 to 1.2)Dairy intervention group 28.3 (4.0) 28.9 (4.6) 0.6 (−0.1 to 1.3)P-value† 0.087 0.388

Mid-arm muscle circumference (cm) <0.001Control group 21.0 (3.3) 16.0 (3.5)a −5.0 (−5.9 to −4.1)Calcium supplemented group 20.5 (1.8) 14.6 (1.6)b −5.9 (−7.5 to −4.3)Dairy intervention group 20.5 (2.6) 18.3 (2.7)a,b −2.2 (−3.1 to −1.2)P-value† 0.920 <0.001

Sum of skinfolds (mm) 0.042Control group 140.1 (34.4) 159.1 (28.3)a 18.8 (11.2–26.5)Calcium supplemented group 138.1 (26.1) 157.9 (14.2) 20.2 (7.1–33.2)Dairy intervention group 134.2 (31.8) 140.9 (25.4)a 6.7 (−0.8 to 14.2)P-value† 0.860 0.025

Waist circumference (cm) 0.080Control group 97.0 (13.2) 89.0 (14.3) −7.9 (−9.8 to −6.1)Calcium supplemented group 97.0 (13.5) 92.4 (15.6) −4.5 (−7.7 to −1.4)Dairy intervention group 91.5 (12.3) 86.0 (11.7) −5.5 (−7.3 to −3.7)P-value† 0.467 0.630

Hip circumference (cm) 0.125Control group 111.1 (10.5) 106.1 (14.3) −5.3 (−9.0 to 1.7)Calcium supplemented group 109.6 (6.9) 104.1 (7.9) −5.9 (−12.2 to 0.4)Dairy intervention group 108.0 (8.5) 107.2 (16.5) −0.4 (−4.0 to 3.2)P-value† 0.388 0.711

T ontrol* differei y inte

effect

ttm

a

TC

A

T

L

T

T*

he statistical analysis performed was repeated measures analysis of variance, cTreatment × time interaction effect. Superscript letters indicate between-groups’nflation in Type-I error: aP < 0.05 dairy intervention vs. control group; bP < 0.05 dair

† Comparison among groups at baseline and 12 months, respectively (Treatment

wo studies reporting weight gains, subjects were given no instruc-ions to adjust for the additional energy intake derived from the

ilk products provided to them [3,35].To our knowledge this is the first study examining changes in

nthropometric and body composition indices, other than body

able 4hanges in the percent (%) of regional and total body fat mass.

Baseline mean (S.D.) 12-months mean (

rms fat mass (%)Control group 42.9 (7.0) 44.3 (8.4)Calcium supplemented group 44.9 (6.1) 45.1 (7.3)Dairy intervention group 43.1 (5.4) 45.8 (8.8)P-valuea 0.635 0.623

runk fat mass (%)Control group 43.5 (4.9) 42.5 (5.6)Calcium supplemented group 44.6 (5.6) 44.9 (6.6)Dairy intervention group 43.1 (5.2) 42.3 (5.5)P-valuea 0.801 0.428

egs fat mass (%)Control group 45.2 (5.8) 44.1 (6.4)Calcium supplemented group 42.7 (4.8) 43.6 (5.5)Dairy intervention group 45.4 (5.6) 43.9 (6.1)P-valuea 0.286 0.936

otal body fat mass (%)Control group 43.6 (4.8) 42.9 (5.7)Calcium supplemented group 42.9 (4.0) 43.4 (4.9)Dairy intervention group 43.6 (5.1) 43.3 (5.8)P-valuea 0.825 0.856

he statistical analysis performed was repeated measures analysis of variance, controlTreatment × time interaction effect.

a Comparison among groups at baseline, 5 and 12 months, respectively (treatment effe

ling for age, energy intake and physical activity levels of the study participants.nces derived by post hoc multiple comparisons using Bonferroni rule, correct thervention vs. calcium supplemented group.).

weight, BMI, total body fat and lean mass, following supplementa-tion either with calcium or with dairy products in postmenopausalwomen. With regards to anthropometric indices the changesobserved in MAMC, an index of lean body mass, as well as in thesum of skinfolds’ thickness (i.e. triceps, biceps, subscapular and

S.D.) 12-month change mean change (95% C.I.) Treatment × time*

0.2401.2 (−0.6 to 3.2)0.1 (−2.8 to 3.0)2.8 (−1.1 to 4.5)

0.296−1.1 (−2.0 to 0.1)

0.3 (−1.2 to 1.7)−0.7 (−1.5 to 0.2)

0.035−0.9 (−1.9 to 0.03)

0.9 (−0.8 to 2.1)−1.6 (−2.4 to −0.7)

0.305−0.7 (−1.5 to 0.1)

0.5 (−0.8 to 1.8)−0.2 (−1.0 to 0.5)

ling for age, energy intake and physical activity levels of the study participants.

ct).

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64 Y. Manios et al. / Maturitas 62 (2009) 58–65

Table 5Changes in regional and total body lean tissue mass.

Baseline mean (S.D.) 12-months mean (S.D.) 12-month change mean change (95% C.I.) Treatment × time*

Arms lean mass (%) 0.257Control group 55.6 (6.9) 54.2 (8.3) −1.3 (−3.2 to 0.6)Calcium supplemented group 53.5 (6.1) 53.4 (7.2) −0.05 (−3.0 to 2.9)Dairy intervention group 55.3 (5.4) 52.7 (8.7) −2.7 (−4.4 to −1.0)P-value† 0.603 0.617

Trunk lean mass (%) 0.322Control group 55.6 (4.9) 56.6 (5.6) 1.1 (0.1–2.0)Calcium supplemented group 54.6 (5.6) 54.2 (6.6) −0.3 (−1.8 to 1.2)Dairy intervention group 55.9 (5.3) 56.7 (5.6) 0.6 (−0.2 to 1.5)P-value† 0.816 0.454

Legs lean mass (%) 0.026Control group 53.2 (5.8) 54.2 (6.5) 1.0 (−0.1 to 2.0)Calcium supplemented group 55.7 (4.9) 55.0 (5.5) −0.7 (−2.1 to 0.7)Dairy intervention group 52.9 (5.7) 54.4 (6.2) 1.5 (0.7–2.4)P-value† 0.342 0.937

Total body lean mass (%) 0.369Control group 55.0 (4.8) 55.6 (5.8) 0.6 (−0.2 to 1.5)Calcium supplemented group 55.7 (4.0) 55.2 (4.9) −0.5 (−1.8 to 0.9)Dairy intervention group 54.8 (5.2) 55.2 (5.9) 0.3 (−0.5 to 1.0)P-value† 0.768 0.841

T ntrollit tmentd n in Ty

t effe

sipDbiwfia

apoalnTdtopbaprt

hcmclBcocfoia

he statistical analysis performed was repeated measures analysis of variance, cohe case of legs lean mass the analysis was also controlled for baseline values. *Treaerived by post hoc multiple comparisons using Bonferroni rule, correct the inflatio† Comparison among groups at baseline, 5 and 12 months, respectively (treatmen

uprailliac), an index of fat body mass, were in favour of subjectsn the DG compared to the CG and the CaG. Regarding body com-osition indices derived from DXA measurements, subjects in theG were also found to have a greater decrease in the percent of fatody mass and a higher increase in the percent of lean body mass

n the lower parts of the body (i.e. feet, hips and pelvis) comparedith the two other groups. These could be considered as interestingndings since older women are very susceptible to adipose tissueccumulation and muscle mass loss in this body region [36].

A limitation of the present study could be the fact that the healthnd nutrition education component of the intervention schemerovided only to the DG subjects, could have induced an extra effectn their health and dietary habits that could subsequently haveffected their weight and body composition status as well. Anotherimitation of the present study could be the unintentional but sig-ificant decrease in energy intake observed for the CG subjects.his decrease could provide an explanation for the non-significantecreases observed in this group for body weight, BMI, total body,runk and legs’ fat mass. Furthermore, the current study was notriginally designed to evaluate the effect of calcium and dairyroducts on body weight and body composition and this coulde another limitation. However, this could also be considered asstrength of the present study since no emphasis whatsoever wasut on weight loss and body weight regulation and therefore theesults could be regarded as unbiased in terms of expectations tohe efficacy of the respective treatments.

In summary the current study revealed that the application of aolistic intervention approach combining nutrition education andonsumption of dairy products fortified with calcium and vita-in D3 for a period of 12 months can lead to certain favourable

hanges in MAMC, sum of skinfolds’ thickness, legs’ fat and leg’sean body mass while no changes were observed in body weight,MI, total fat and total lean body mass. Furthermore, no significanthanges either in anthropometric or body composition indices werebserved for the CaG after supplementation of the recommended

alcium dose. The favourable findings observed in the present studyor the DG could have important implications for the prevention ofbesity, especially in light of the marginal calcium intakes exhib-ted by the majority of the population of postmenopausal womennd the epidemiological data indicating protection from obesity

ng for age, energy intake and physical activity levels of the study participants. In× Time interaction effect. Superscript letters indicate between-groups’ differencespe-I error; bP < 0.05 dairy intervention vs. calcium supplemented group.

ct).

and insulin resistance in populations consuming greater amountsof dairy products [5,37]. Still it is not yet safe to claim conclusivelythat increasing the consumption of dairy foods results in a reduc-tion in body weight or fat mass [7]. Further research is needed toconfirm the exact effect of dairy products on body composition andto identify other less studied bioactive compounds of dairy prod-ucts, such as conjugated linoleic acid, branched-chain amino acidsand whey proteins [18], that could act synergistically with calciumto regulate fat metabolism within the adipocyte.

Acknowledgements

The authors would like to thank Eva Grammatikaki, IoannaKatsaroli and Paraskevi Kannelou, dieticians for their valuablecontribution in data collection and processing. The study was sup-ported by a research grant from Friesland Foods Hellas. YannisManios also works as a part-time scientific consultant for Fries-land Foods Hellas. All other authors had no potential conflict ofinterest. The study sponsor had no role in the study design; the col-lection, analysis, or interpretation of the data; the writing of themanuscript; the submission and revision of the paper.

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