HCG for Weight Loss Ryan Shelton, ND. Literature Well designed, prospective, randomized, double-blind studies –Positive 1, Negative 1 Less well designed.

HCG for Weight LossHCG for Weight Loss

Ryan Shelton, NDRyan Shelton, ND

LiteratureLiterature

Well designed, prospective, randomized, double-blind studies– Positive 1, Negative 1

Less well designed studies– Positive 6, Negative 5

HCGHCG

Glycoprotein hormone produced by Glycoprotein hormone produced by embryo soon after conception and embryo soon after conception and then by the placenta then by the placenta

Produced early and gradually Produced early and gradually increases through 1increases through 1stst trimester (1 trimester (1stst wk 5-50 IU/L; 13wk 5-50 IU/L; 13thth wk 12,000-250,000 wk 12,000-250,000 IU/L)IU/L)

Gradual fall to around 4,000 IU/L Gradual fall to around 4,000 IU/L throughout 2throughout 2ndnd & 3 & 3rdrd trimesters trimesters

HCG StructureHCG Structure Large molecule, high negative chargeLarge molecule, high negative charge

– Oligosaccharide side chains presentOligosaccharide side chains present– 36.7 kDaltons; 7.5X3.5X3nm36.7 kDaltons; 7.5X3.5X3nm

Similar in structure to other glycoprotein Similar in structure to other glycoprotein hormones (LH, FSH, TSH)hormones (LH, FSH, TSH)– Serum levels >200IU/L can induce hyperthyroidismSerum levels >200IU/L can induce hyperthyroidism– Most similar to LHMost similar to LH

Stimulates interstitial cells of testis to produce androgens Stimulates interstitial cells of testis to produce androgens and corpus luteum of ovary to produce progesteroneand corpus luteum of ovary to produce progesterone

Two subunits: alpha & betaTwo subunits: alpha & beta– Alpha identical to LH, FSH, TSHAlpha identical to LH, FSH, TSH– Alpha 92 amino acids; Beta 145 amino acidsAlpha 92 amino acids; Beta 145 amino acids

Beta subunit is uniqueBeta subunit is unique

HCG PharmacokineticsHCG Pharmacokinetics AbsorptionAbsorption

– BioavailabilityBioavailability SQ 40%; IM 60%SQ 40%; IM 60% SQ delayed peak, lower peak, lower AUC relative to IM SQ delayed peak, lower peak, lower AUC relative to IM

though produced equivalent steroidogenesisthough produced equivalent steroidogenesis Poor sublingual bioavailabilityPoor sublingual bioavailability

– Onset & DurationOnset & Duration IM: initial 2hrs, peak 6hrs; Undetectable after 72 hrsIM: initial 2hrs, peak 6hrs; Undetectable after 72 hrs SQ: Peak 16hrsSQ: Peak 16hrs

MetabolismMetabolism– Proximal tubule of kidney or excreted unchangedProximal tubule of kidney or excreted unchanged

ExcretionExcretion– Renal excretionRenal excretion– Elimination half-life prolonged 25% with SQ over Elimination half-life prolonged 25% with SQ over

IM doseIM dose

HCG MetabolismHCG Metabolism Half life 29 +/- 6hrsHalf life 29 +/- 6hrs Diencephalon (specifically the hypothalamus) has the highest Diencephalon (specifically the hypothalamus) has the highest

concentration of receptorsconcentration of receptors Receptors on ovaries, uterus, testes, dermal fibroblastsReceptors on ovaries, uterus, testes, dermal fibroblasts

– Can induce ovulation in ovaries, produce testosterone in Can induce ovulation in ovaries, produce testosterone in testestestes

Debate about presence of receptors on adipocytesDebate about presence of receptors on adipocytes PregnancyPregnancy

– Maintains corpus luteum and increases progesteroneMaintains corpus luteum and increases progesterone– Repel immune cellsRepel immune cells– Collagen and elastin from fibroblastsCollagen and elastin from fibroblasts

Non-pregnant stateNon-pregnant state– May increase adiponectin; may increase leptin receptor May increase adiponectin; may increase leptin receptor

sensitivitiessensitivities Mood/appetiteMood/appetite Improve brain/adipocyte communicationImprove brain/adipocyte communication May induce fat redistributionMay induce fat redistribution Rapid weight loss does significantly decrease Rapid weight loss does significantly decrease

testosterone, thyroid and LH levelstestosterone, thyroid and LH levels

Possible mechanisms for Possible mechanisms for weight lossweight loss

AdiponectinAdiponectin– Secreted by adipose tissueSecreted by adipose tissue– Fatty acid catabolism, suppression of DM, Fatty acid catabolism, suppression of DM,

obesity, NAFLD, hungerobesity, NAFLD, hunger TestosteroneTestosterone

– Lean body mass, fatty acid catabolismLean body mass, fatty acid catabolism– ¼ of testosterone in females produced by ¼ of testosterone in females produced by

ovariesovaries DopamineDopamine

– Dopamine can inhibit HCG binding to HCG Dopamine can inhibit HCG binding to HCG receptorreceptor

– Beta-endorphin levels increased by HCG Beta-endorphin levels increased by HCG administrationadministration

Fat LossFat Loss

Bi-phasic response clinicallyBi-phasic response clinically– Low dose: weight lossLow dose: weight loss– High dose: weight gainHigh dose: weight gain

Fat loss vs weight lossFat loss vs weight loss Fat loss rateFat loss rate

– Males: ½-1lb/dMales: ½-1lb/d– Females: 1/3-1/2 lb/dFemales: 1/3-1/2 lb/d

Abnormal fat lossAbnormal fat loss– Neck, arms, midriff, hips, thighsNeck, arms, midriff, hips, thighs

HCG LegalitiesHCG Legalities FDA approved for testicular descent, hypogonadism, FDA approved for testicular descent, hypogonadism,

infertilityinfertility HCG not FDA approved for weight lossHCG not FDA approved for weight loss

– Off label use; >60% of all Rx are off label (OCP, Off label use; >60% of all Rx are off label (OCP, Wellbutrin, Gabapentin, Adderall, Sertraline)Wellbutrin, Gabapentin, Adderall, Sertraline)

Informed consentInformed consent– Off labelOff label– Coupled w VLCDCoupled w VLCD– Lose weight on VLCDLose weight on VLCD

HCG is not DEA controlledHCG is not DEA controlled HCG is Schedule III controlled substance in some HCG is Schedule III controlled substance in some

statesstates– CA, CO, CT, LA, MN, NV, NY, NC, PA, RICA, CO, CT, LA, MN, NV, NY, NC, PA, RI– Completely restricted for weight loss in LouisianaCompletely restricted for weight loss in Louisiana

HCG and TumorsHCG and Tumors

Some studies show HCG is protective Some studies show HCG is protective for BRCAfor BRCA

Some types of tumors produce HCGSome types of tumors produce HCG– Seminoma, Choriocarcinoma, Germ cell Seminoma, Choriocarcinoma, Germ cell

tumor, Hydatiform mole, Islet cell tumortumor, Hydatiform mole, Islet cell tumor– Likely to evade immune systemLikely to evade immune system

Tumor marker different than cause of Tumor marker different than cause of tumortumor– AFP, Ca, PTH, ALPAFP, Ca, PTH, ALP

HCG for Weight LossHCG for Weight Loss

Use began in 1954 by Dr Albert Use began in 1954 by Dr Albert SimeonSimeon– Based on work with Adiposogenital Based on work with Adiposogenital

dystrophy patientsdystrophy patients– Strict protocol written in Strict protocol written in Pounds and Pounds and

InchesInches Slight variation of protocol developed Slight variation of protocol developed

by Dr Daniel Belluscio in 1987by Dr Daniel Belluscio in 1987 Many different protocols now being Many different protocols now being

utilizedutilized

Original HCG DietOriginal HCG Diet Strict total calorie intake: 500cal/dStrict total calorie intake: 500cal/d Low glycemic foods onlyLow glycemic foods only No artificial sweetnersNo artificial sweetners No added fats or oils (including topical)No added fats or oils (including topical) Menu planMenu plan

– BreakfastBreakfast Tea, coffee, water; unsweetened, 1 Tbsp/d of milkTea, coffee, water; unsweetened, 1 Tbsp/d of milk

– LunchLunch 100g (3.5oz) raw weight protein boiled, broiled, grilled; fat 100g (3.5oz) raw weight protein boiled, broiled, grilled; fat

removedremoved– Veal, beef, bison, chicken breast, turkey breast, white Veal, beef, bison, chicken breast, turkey breast, white

fish, shrimp, crab, lobster, salmonfish, shrimp, crab, lobster, salmon Serving (1-2c) of vegetables; cooked or rawServing (1-2c) of vegetables; cooked or raw

– Spinach, chard, chicory, beet-greens, green salad, Spinach, chard, chicory, beet-greens, green salad, tomatoes, celery, fennel, onions, radish, cucumbers, tomatoes, celery, fennel, onions, radish, cucumbers, asparagus, cabbageasparagus, cabbage

– NO potatoes, corn, carrots, legumesNO potatoes, corn, carrots, legumes One Melba toastOne Melba toast Fruit as desert at end of mealFruit as desert at end of meal

– Citrus, apple, berries, cherriesCitrus, apple, berries, cherries– DinnerDinner

Same as lunchSame as lunch– NO snacksNO snacks

HCG Diet AlternativesHCG Diet Alternatives

Many clinics use higher calories with Many clinics use higher calories with good successgood success– 600-1250 adjusted for physical activity600-1250 adjusted for physical activity

Low-glycemic, ketogenicLow-glycemic, ketogenic– Similar to Atkins or Zone with more Similar to Atkins or Zone with more

focus on quantity and quality of fatfocus on quantity and quality of fat Small amounts of natural sweeteners Small amounts of natural sweeteners

allowed (stevia, agave); topical allowed (stevia, agave); topical agents allowedagents allowed

Original HCG Diet ScheduleOriginal HCG Diet Schedule Injection cycle limited to 23-40 daysInjection cycle limited to 23-40 days

– Tolerance (hunger)Tolerance (hunger)– Never <23 or >40Never <23 or >40

Diet cycle limited to 26-43 daysDiet cycle limited to 26-43 days– Continue on 500 calorie diet 3 days p last HCG injectionContinue on 500 calorie diet 3 days p last HCG injection– Increase calorie intake to 800-1000 cal/d if weight loss goal Increase calorie intake to 800-1000 cal/d if weight loss goal

reached prior to day 23reached prior to day 23– Weight loss limited to 34lbs per cycleWeight loss limited to 34lbs per cycle

Load high fat on 1Load high fat on 1stst three days of HCG three days of HCG Break taken during menstruationBreak taken during menstruation After diet cycle, 3 weeks of higher calorie low After diet cycle, 3 weeks of higher calorie low

glycemicglycemic Minimum six week break required between each 40 Minimum six week break required between each 40

d cycled cycle– Subsequent intervals should be progressively longer Subsequent intervals should be progressively longer

Alternative HCG Diet Alternative HCG Diet ScheduleSchedule

Injections for 6 days, take every 7Injections for 6 days, take every 7thth day offday off

No breaks during menstruationNo breaks during menstruation IF weight loss slows down around 6 IF weight loss slows down around 6

weeks, need to take a breakweeks, need to take a break

HCG PrecautionsHCG Precautions Close F/U requiredClose F/U required ContraindicationsContraindications

– Active cancer, Type I diabetes, Recent Hx eating disorder, Active cancer, Type I diabetes, Recent Hx eating disorder, Prior allergic reaction, Pregnancy/Lactation, AUB, Prior allergic reaction, Pregnancy/Lactation, AUB, Uncontrolled intracranial lesion, Uncontrolled endocrine Uncontrolled intracranial lesion, Uncontrolled endocrine dysfunctiondysfunction

PrecautionsPrecautions– PCOS, Hx thrombotic conditions, Blood-thinning Rx, Hx PCOS, Hx thrombotic conditions, Blood-thinning Rx, Hx

Kidney disease, Hx liver disease, CHF, Arrhythmias, Gout, Kidney disease, Hx liver disease, CHF, Arrhythmias, Gout, Risk of fluid retentionRisk of fluid retention

Side-effectsSide-effects– Headache, restlessness, irritability, fatigue, nausea, Headache, restlessness, irritability, fatigue, nausea,

menstrual changes, mastodynia, pain/bruising/pruritus at menstrual changes, mastodynia, pain/bruising/pruritus at injection site, edema, gynecomastia, hyperglycemia, injection site, edema, gynecomastia, hyperglycemia, ovarian hyperstimulationovarian hyperstimulation

– Consider supplementing with minerals/electrolytes, Consider supplementing with minerals/electrolytes, EPA/DHAEPA/DHA

– Monitor BP, thyroid, electrolytes, urinary ketone production, Monitor BP, thyroid, electrolytes, urinary ketone production, E2 in males?, muscle mass if BIA availableE2 in males?, muscle mass if BIA available

HCG Dosage HCG Dosage 125-150 IU/d for most patients125-150 IU/d for most patients 200 IU/d can be used for very obese200 IU/d can be used for very obese Can adjust dose for plateau Can adjust dose for plateau 125 IU/0.1mL is typical125 IU/0.1mL is typical

– 0.1mL/d sq abdomen, thigh, buttocks0.1mL/d sq abdomen, thigh, buttocks Can reconstitute in as little as 1.0 ml diluentCan reconstitute in as little as 1.0 ml diluent Commercial vial 10,000IUsCommercial vial 10,000IUs

– Caution: More than most patients needCaution: More than most patients need– Increasing the dose does not increase the weight lossIncreasing the dose does not increase the weight loss

Stable for 60 day (refrigerated)Stable for 60 day (refrigerated)– Room temperature stability only 24 hrsRoom temperature stability only 24 hrs

Other optionsOther options– IM injection (usually bi-weekly)IM injection (usually bi-weekly)– Nasal SprayNasal Spray– SublingualSublingual

62.5 IU bid-tid62.5 IU bid-tid

Physician ServicesPhysician Services

Fee foe service: $500 for each 40 Fee foe service: $500 for each 40 day course plus cost of HCG is typicalday course plus cost of HCG is typical

Initial physical exam and Initial physical exam and consultationconsultation– Internet prescribing not allowedInternet prescribing not allowed

Weekly or bi-monthly F/U visitsWeekly or bi-monthly F/U visits– Weight, Body measurementsWeight, Body measurements– Review food intake logReview food intake log

Additional ThoughtsAdditional Thoughts ExerciseExercise

– Excess can cause slower weight loss, fatigue, muscle mass Excess can cause slower weight loss, fatigue, muscle mass loss especially the first 2 weeks of dietloss especially the first 2 weeks of diet

CravingsCravings– Different than hungerDifferent than hunger

PlataeuPlataeu– Compliance, constipation, hormone shifts, toxicityCompliance, constipation, hormone shifts, toxicity

Adjunctive therapiesAdjunctive therapies– Electrolytes, fiber, hydration, EFAs, DetoxElectrolytes, fiber, hydration, EFAs, Detox

Endocrine system must be balanced prior to Endocrine system must be balanced prior to beginning dietbeginning diet

SourcesSources– Urine derived, recombinantUrine derived, recombinant– Obtain C of AObtain C of A

Suggested ResourcesSuggested Resources

Albert Simeon, MD, Albert Simeon, MD, Pounds and Pounds and InchesInches

www.hcgdietinfo.com Daniel Belluscio, MDDaniel Belluscio, MD www.hcgobesity.org [email protected]