S OY AND H EALTH 1. This activity is partially supported by educational funding received from the United Soybean Board. Printable handout available at.

SOY AND HEALTH1

This activity is partially supported by educational funding received from the United Soybean Board.

Printable handout available at AANP CE Center.

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FACULTY

Cindy Cooke MSN, NP-C, FAANP FNP - Fox Army Health Center, Huntsville, AL

Joyce M. Knestrick, PhD, CRNP, FAANP Coordinator of Graduate Education- Frontier

School of Midwifery and Family Nursing, Hyden, KY

FNP –Primary Care Center of Mt. Morris, PA

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DISCLOSURES

The faculty have no relationships to disclose.

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LEARNING OBJECTIVES

On completion of this activity, participants will be able to: Discuss the nutrients available in soy products. Identify sources of soy and the nutritional value

of various sources Discuss ways in which soy products can be

incorporated in diet Discuss recommendations and supporting

evidence regarding soy as relates to specific conditions

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CONSUMERS AND NUTRITIONAL INFORMATION

88% of consumers report reviewing Nutrition Facts panel when purchasing food.

48% of consumers find nutrition information confusing.

Most frequently consumers look for Calorie content (16%) Fat content (11%)

United Soybean Board (2009). 16th annual survey: Consumer attitudes about nutrition. 6

CONSUMER SOY KNOWLEDGE

84% respondents rate soy products as healthy

30% reportedly seek out soy products Reported benefits:

Low fat (19%) Good protein source (18%) Associated with reduced rate of heart disease

(18%) Associated with lowered cholesterol (13%)

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SOURCE OF SOY KNOWLEDGE

Reported sources of information regarding health and nutrition information on soy: HCPs 16% Internet 42% Television 41% Magazines 40%

Need for HCPs to be informed regarding soy and other dietary factors, to provide individualized instruction

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SOY PRODUCTION DETAILS

US produces 42% of world’s soybeans Significant portion of US soybeans exported Soybeans account for 75% of U.S. edible fat

and oil consumption Flakes remaining after oil extraction used to

produce wide range of high protein products

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SOYBEAN

Beans generally good source of nutrients Soybeans include 47% fat energy, higher

than other beans Higher in calcium and iron than other beans Lower in B vitamins, crude fiber

Katcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38, 45-78.

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SOYFAT

Mono and Poly unsaturated No cholesterol Omega-3 fatty acid, alpha-linolenic acid Omega-6 fatty acids, linolenic acid

Important essential fatty-acids Must be obtained through diet/intake Roles in brain function, skin/hair growth, bone

health, metabolism peripheral vascular function, reproduction

Katcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38, 45-78. 11

PROTEIN

Vegetarian source of total protein 36% of the total bean

Contains all essential amino acids Staple of Asian diet In U.S. Recommendations often indicate 25-

50 Gm soy protein daily

Katcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38, 45-78.

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CONCENTRATED SOY SOURCES

Concentrated sources of soy protein include:

Soy protein powder (80-90%) Soy nuts (40%) Full-fat soy flour (35%)

To consume 50 gm/day—example:1 soy breakfast patty, 8 oz soy milk, 3 oz tofu, 1 oz

soy nuts, 2 heaping tablespoons of soy protein

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SOY INTAKE AND ISOFLAVONES Soy products vary in isoflavone content

25 G soy protein : 100 mg isoflavone Differs depending on processing, additives, etc.

Estrogen-like activity through selective estrogen receptor modulator (SERM) activity Act as phytoestrogens

Isoflavone pharmacokinetics: Peak 5-6 hr after ingestion Half-life 6-8 hrs Uptake is saturable, limiting benefit of large

consumption Isoflavone content of foods varies between batches

Setchell, K. (2001). Soy isoflavones—Benefits and risks from nature’s selected estrogen receptor modulators (SERMs), Journal of the American College of Nutrition, 20 (5), 354S-362S.

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COMMON SOY PRODUCTS: GLOSSARY & NUTRITION

Edamame: Large soybeans harvested while green; boiled 10-20 minutes can be served as snack or vegetable; available shelled and in pods; available fresh and frozen 1 cup= 22 g protein, 12 g fat, 20 g CHO, 8 g fiber, 254 cal

Soybeans: mature beans, ripened dry, varied colors. Can be roasted once soaked; often cooked in soups, stews, etc 1 cup=68g protein, 37 g fat, 56 g CHO, 14 g fiber, 776 cal

(roasted)

Soynuts: roasted soybeans; varied flavors available Soybean oil: natural oil extracted from soybeans;

~75% total US fat/oil consumption; also used in margarine and shortenings 1 cup=0 g protein, 218 g fat, 0 g CHO, 0 g fibre, 1664 cal

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COMMON SOY PRODUCTS: GLOSSARY & NUTRITION Soymilk: Made from soybeans soaked, ground, and

strained; found in unrefrigerated section and refrigerated dairy cases; also used to make soy yogurt, soy cheese, etc 1 cup=7 g protein, 5 g fat, 8 g cho, 1 g fiber, 109 calories

Tofu: Made from curdled soymilk, soft cheese-like food; bland, variety of uses 1 cup-6 g protein, 2 g fat, 2 g cho, 0 g fiber, 52 cal

Tempeh: Chunky tender soybean cake, used in variety of foods 1 cup-5 g protein, 3 g fat, 3 g cho, 0 g fiber, 55 cal

Miso: Condiment common to Japanese cooking; aged paste of soybean and grain 1 cup=2 g protein, 1 g fat, 5 g cho, 1 g fiber, 40 cal

Soy flour: Ground roasted soybeans; 50% protein, higher protein value if defatted 1 cup=48 g protein, 0 g fat, 27 g cho, 17 g fiber, 394 cal

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HEALTH EFFECTS/CLAIMS

Cancer Risks Bone Health Menopause Symptoms Heart Disease Healthy eating

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MR. ALLEN

42 years old weight 280 pounds; 70 inches tall

Last visit 3 months ago weight 310 On a high protein diet for 3 months

Eating mostly meats/salads, very little fish Becoming bored with diet

Asks about adding soy products to his diet Has heard soy products high in protein and

available in varied forms

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MRS. COMER

48 years old Weight 158 pounds; height 5’4” Concerned about her cholesterol

Most recent: TC 210, HDL 35, LDL 125 Watching her diet and increasing exercise Asks about adding soy to her diet to lower

cholesterol Questions:

How soy works to lower cholesterol Will products be harmful or make her gain weight How much soy would need to be consumed to

help lower her cholesterol. 19

MRS. RICK

50 years old, with complaints of hot flashes Last pap smear normal Has not missed any periods; flow is heavier Does not want to take any medications for the

hot flashes. Sister- in- law suggested use of soy milk Has been drinking the soy milk in place of cow’s milk

for 3 weeks Has not noticed any changes in the hot flashes Would like to continue to try the soy milk

She has less bloating and flatulence since drinking the soy milk

Questions if the substitution of soy milk in place of cow’s milk will have an effect on her bones. 20

HOW TO RESPOND TO PATIENTS?

As part of healthy diet, soy products considered part of nutrition/diet

As part of a treatment plan to prevent or treat specific conditions, soy products best considered part of complementary therapy plan

Base responses accordingly

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CONSIDERING COMPLEMENTARY OPTIONS

Rakel identifies questions to be considered in recommending “complementary” therapies Will the therapy result in resolution or symptom

suppression? What is the evidence? What is the potential harm? What is the cost? Does the treatment fit patient’s culture and

belief system?

Rakel, D. (2006). Complementary medicine in clinical practice. Philadelphia: Elsevier.

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CHALLENGES REGARDING EVIDENCE

Regarding the evidence-base for integrative or complementary measures, Rakel identifies challenges, including: Clinical trials typically measure response to one

treatment, while integrative measures usually part of a “package”

Many integrative measures are not administered in one standardized portion, but individualized

Controlled studies often look at short-term outcomes rather than long-term

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MORE INFORMATION NEEDED

In order to consider use of soy products as part of complementary treatment plan, must consider the evidence to help answer questions

Will review summary literature regarding soy effects related to specific health conditions

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REGARDING SOY AND CANCER

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WHAT ARE EFFECTS OF SOY ON BREAST AND PROSTATE CANCER RISKS?

Asian diet includes soy products Asians have lower rates of breast and prostate

cancers

Investigations of effects of soy in cancer risk are limited

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BREAST CANCER

Asian studies A Singapore and a Japan study each found soyfoods

consumption associated with lower rate of BCA in pre-menopausal females, not in post-menopausal

China study failed to demonstrate either relationship

U.S Studies One US trial demonstrated protective relationship only in women

born in Asia who migrated to U.S. Meta-analysis of 18 studies cite decreased breast cancer

associated with higher soy consumption, strongest in post-menopausal women

Inconclusive thus far whether positive benefits

Wu, A.,et al (2008). Soy intake and breast cancer risk in Singapore Chinese Health Study. British Journal of Cancer ,99:196-200.

Qin, L., Xu, J., & Wan, P. (2006). Soyfood intake in the prevention of breast cancer risk in women: A meta-analysis of observational epidemiological studies. Journal of Nutritional Science, 52 (6), cited in Michelfelder 92009). Soy: A complete source of Protein, 79 (1), 43-47.

Trock, B., Hilakivi-Clarke, Ll, & Clarke, R. (2006). Meta-analysis of soy intake and breast cancer risk. Journal of the American Cancer Institute, 98 (7), 459-471

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CONCERNS RELATED TO SOY AND ESTROGEN-SENSITIVE CANCER

Isoflavones SERM activity—theoretical concerns regarding

potential role of soy/isoflavone in women at risk for estrogen-sensitive breast cancer

Studies typically measure breast density and/or markers for cancer

No studies have confirmed, but generally advised to counsel women regarding this risk

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PROSTATE CANCER

Limited human study Asians lower rate of prostate cancer

US Asian immigrants rate similar to US rate 1989 publication: Tofu consumption

associated with marked but not statistically significant decrease in PCA

US study daily soymilk intake associated with decrease incidence PCA

Inadequate research for conclusions

Severson, R., et al (1989). A propsiective study of demgraphis, diet, and prostate cancer amon men of Japanese ancestry in Hawaii. Cancer Research, 49, 1875-1860.

Jacobsen BK et al . (1998) Does high soy milk reduce prostate cancer incidence? The Adventist Health Study (United States). Cancer Causes Control 9: 553-557

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REGARDING SOY AND BONE HEALTH

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SOY BONE HEALTH Japanese women lower rate of hip fractures Lower rate could be due to anatomical

differences or fall risk, as bone density similar Chinese women: higher soy intake associated

with decreased fracture risk RCT demonstrated soy protein associated with

decreased bone turnover markers, without density change

Few human studies, which demonstrate inconsistent effects, preliminary

Zhang, X., et al (2005). Prospective cohort study of soy food consumption and risk of bone fracture among postmenopausal women. Archives of Internal Medicine, 166 (16), 1890-1895.

Evans et al (2007). Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women. Menopause. 2007 14,481-488.

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REGARDING SOY AND MENOPAUSE SYMPTOMS

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MENOPAUSAL SYMPTOMS

Estrogen-like activity of soy attributed to lessening of menopausal symptoms (SERM activity)

Japanese women lower incidence of menopausal symptoms

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MENOPAUSE EVIDENCE

Meta-analysis of 11 studies: mixed results in hot flash reduction

Meta-analysis of 17 studies reduction in women with 10 or more hot flashes/day; no effect if <6 hot flashes/day

Recent RCT soy associated with reduction in women, <4.5/>4.5 hot flashes/day

Other studies have demonstrated similar response to placebo

Nelson, et al. (2006). Nonhormonal therapies for menopausal hot flashes: Systematic review and meta-analysis. JAMA (295 (17), 20575-2071.

Howes, L., Howes, J., & Knight, D. (2006). Isoflavone therapy for menopausal flashes: A systematic review and meta-analysis. Maturitas, 55 (3), 203-211.

Weity, F, et al (2007). Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women. Menopause, 15 (1), 125-132.

Newton, K., et al (2006). Treatment of vasomotor symptoms of menopause with black cohosh, mutibotanicals, soy, hormone therapy, or placebo: A randomized trail. Annals of Internal Medicine 145 (12), 869-879.

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AHRQ Effects of soy on menopausal symptoms

inconsistent, but stronger with isoflavone supplements

Identified study issues include: Varied symptom scores, score intervals

Decreased weekly frequency reported 7-40% No apparent effect on menstrual cycles, TSH,

bone markers, glucose metabolism

Soy products generally well-tolerated

Balk, E. et al (2005). Effects of Soy on Health Outcomes. Evidence Report/Technology Assessment No. 126. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract No. 290-02-0022.) AHRQ Publication No. 05-E024-2. Rockville, MD: Agency for Healthcare Research and Quality.

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REGARDING SOY AND HEART EFFECTS

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HYPERLIPIDEMIA FDA approved health claim: “Diets low in

saturated fats and cholesterol that include 25 g of soy protein a day may reduce the risk of heart disease” To qualify for claim, food must contain at least

6.25 g soy protein, or 25% of RDA Statement based on review of 27 studies

National Cholesterol Education Program recommends soy protein as replacement for higher-fat animal proteins

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SOY & LIPIDS: BODY OF EVIDENCE

Four meta-analyses demonstrated statistically significant reduction in TC up to 9.3%, with greater effect associated with higher starting TC levels

Varying results, but generally mildly positive

Anderson, J., Johnstone, B., Cook-Newell, M (1999). Meta-analysis of the effects of soy protein intake on serum lipids. NEJM, 333 (5), 276-282.

Nies, L.,Cymbalta, A., Kasten S., et al (2006). Complementary and alternative therapies for the management of serum lipids. Annala of Pharmacotherapy, 40(11), 1984-1992.

Reynolds, K., et al (2006). A meta-analysis of the effect of soy protein supplementation on serum lipids. American Journal of Cardiology, 98 (5), 633-640.

Zhua, X., Melby, M., & Watanabe, S. 2004). Soy isoflavone intake lowers serum LDL cholesterol: A meta-analysis. Journal of Nutrition, 134 (9), 2395-2400.

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More recent meta-analyses demonstrated more modest, but favorable effects on lipids Intake of 30-50 g soy protein/day associated with

3-5% reduction in LDL-C Limited studies yet demonstrating improved

long-term outcomes Only one study (Shanghai Women’s Health

Study) provides evidence that increased soy consumption may decrease risk of non-fatal MI and CHD or cardiac events

Zhang, et al (2003). Soy food consumption is associated with lower risk of coronary heart disease in Chinese women. Journal of Nutrition, 133, 2874-2878.

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AHRQ META-ANALYSIS

178 eligible articles Supplements (including soy milk) in 75% Soy foods (soy flour and textured soy protein)

25% Most soy protein with isoflavones 1/3 isoflavones alone Few protein alone Mean 36 g/day (14-154 g/day)

36 g=1 # tofu

Balk, E. et al (2005). Effects of Soy on Health Outcomes. Evidence Report/Technology Assessment No. 126. (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract No. 290-02-0022.) AHRQ Publication No. 05-E024-2. Rockville, MD: Agency for Healthcare Research and Quality.

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ISSUES RELATED TO SOY-HEART STUDIES

Heterogenicity in types of soy, doses, durations, etc

Lipids-small benefit on LDL (mean net change -5 mg/dl) TG (mean net change -9 mg/dL)

Greater benefit associated with higher baselines and dosages

No significant effect on BP No significant effect on HDL Markers of inflammation, vascular function, lipid

oxidation

Balk, E. et al (2005).

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Greater benefit associated with higher baselines and dosages

Whole soy protein greater effect than isoflavone components

Lack of support for soy protein association with decreased cardiac events

Michelfelder, A. (2009). Soy: A complete source of protein. American Family Physician, 79 (1). 43-47

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REGARDING SOY AS PART OF HEALTHY EATING

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NUTRITIONAL CONSIDERATIONS

Vegetarian diets: Soy provides protein substitute for meat and dairy products

Specific Example: Portfolio diet example Low in saturated fat, high in fiber. Designed to

lower cholesterol. Includes soy, fiber, plant sterols, almonds

Soy protein: 22.5 g/day Viscous fiber: 10 g/day oats, barley, psyllium-

containing cereal Plant sterol & stanol esters margarine: 1 g/day Almonds: 15 nuts/day

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Rakel considers the level of evidence and reported benefits for use of soy and fiber in nutritional impact on lipids, as well as potential risks/hazards. Reported benefit with limited risk, recommended

Recommends soy products with both protein and isoflavones Mixed results

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POTENTIAL ADVERSE EFFECTS Soy generally well-tolerated Adverse effects include:

GI symptoms/diarrhea; menstrual complaints Concern over endometrial hyperplasia, not

supported by recent ROL Potential weak cytochrome P450 3A4 enzyme

inducer, with one reported case lowered INR in warfarin patient related to soy milk

Studies indicate addition of soy formulas decrease infant absorption of iron and thyroid supplementation

Infant soy allergy rate 1% on soy formula; adult soy allergy rate 0.2%

Michelfelder, A. (2009). Soy: A complete source of protein. American Family Physician, 79 (1), 43-27.

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REVISIT SCENARIOS

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MR. ALLEN

42 years old weight 280 pounds; 70 inches tall

Last visit 3 months ago weight 310 On a high protein diet for 3 months

Eating mostly meats/salads, very little fish Becoming bored with diet

Asks about adding soy products to his diet Has heard soy products high in protein and

available in varied forms

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POSSIBLE “TALKING POINTS” Reinforce ongoing effort and motivation Because soy is a protein, it makes you feel less

hungry after eating Soy protein is “low-carb.” Soybeans are the only

vegetable that contain more protein than carbohydrates.

Soy protein has a ”low-glycemic index” that helps with appetite and weight loss.

Soy protein contains all 9 essential amino acids Comparable to meat with less fat and fewer calories.

 Discuss the advantages of using soy products in a high protein diet.

Discuss potential ways in which soy can be incorporated into diet 

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SOME SOY SUGGESTIONS Tofu: Is often used in stir-fries, curries or stews.

It tends to pick up the flavor of the sauce it is in. Soy nuts: Can be used as a snack similar to

peanuts or sunflower seeds Soymilk: Soy milk can be substituted for cow’s

milk Soy burgers, soy cheese, and other

products can be found in many grocery stores usually in the frozen section

Edamame: Sold frozen or fresh the beans can be microwaved or simmered.

Tempeh: It can be used as a meat substitute, and works well in spaghetti sauce.

Miso: It can be used for soup stocks or as a seasoning.

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MRS. COMER 48 years old Weight 158 pounds; height 5’4” Concerned about her cholesterol

Most recent: TC 210, HDL 35, LDL 125 Watching her diet and increasing exercise Asks about adding soy to her diet to lower

cholesterol Questions:

How soy works to lower cholesterol Will products be harmful or make her gain weight How much soy would need to be consumed to

help lower her cholesterol. 51

POTENTIAL “TALKING POINTS” The studies related to the benefits of soy to lower cholesterol are

mixed. Discuss the affects of Soy Products on weight loss or weight gain.  The addition of Soy Products in place of animal protein can lead to a

reduction of weight with decreased calorie/fat consumption An excess intake of any food can lead to weight gain.

 Define the amount of Soy Products that should be consumed in a healthy diet.

Individualized ----

Some studies involved very large quantities of soy foods for benefit

Recommended daily intake of soy products must be reasonable  Soybeans offer a complete protein with nine essential amino acids;

recommendation to substitute soy in place of mean/animal protein

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MRS. RICK 50 years old, with complaints of hot flashes

Last pap smear normal Has not missed any periods; flow is heavier Does not want to take any medications for the hot

flashes. Sister- in- law suggested use of soy milk Has been drinking the soy milk in place of cow’s milk for 3 weeks Has not noticed any changes in the hot flashes Would like to continue to try the soy milk

She has less bloating and flatulence since drinking the soy milk

Questions : Will substitution of soy milk for cow’s milk have an effect

on her bones. Is there any evidence to support the use of soy products

to alleviate her peri-menopausal symptoms? How long would she have to use the soy products before

noticing a difference.

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POTENTIAL “TALKING POINTS” Two soy isoflavones (genistein and diadzein) believed to help

the symptoms associated with peri- menopause and menopause

Effects of soy on menopausal symptoms inconsistent, but decreased weekly frequency 7-40%

 Actions believed to related to SERM activity, blocking the negative effects of estrogen.

 The North American Menopause Society supports eating whole foods containing the following 40-80 mg/day of isoflavones to reduce hot flashes  (3- 4 glasses/day soy milk)

Effects stronger with isoflavone supplements and dose related If no results at higher range, likely will not see response.

Look for results after 4 weeks Ensure calcium supplementation Regarding the changes in her GI tract since switching to soy

milk: may have improved some previously undiagnosed lactose intolerance. Increased amounts of soy milk could cause digestive problems similar to ingestion of other legumes. 54

SUMMARY

Soybeans provide a high protein, low fat option

Studies regarding the dietary effects of soybeans and soy products on specific conditions heterogeneous with varied results

Current FDA recommendations to include 25 g of whole soy protein may decrease risk of heart disease

Other potential benefits of soy products may include decreased menopausal hot flashes, maintenance of bone density, and prevention of certain malignancies 55

SUMMARY

A large number of conditions have dietary interventions that should be considered

There is a growing awareness of and interest in soy products

HCPs should be prepared to discuss dietary measures with patients, using an individualized approach and reflecting relevant evidence

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POST TEST

The post-test for this activity is located on the AANP CE Center.

Credit earned by successful completion of the online post-test.

70% or higher score required.

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