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Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)

Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427529
Enrollment
59
Registered
2015-04-28
Start date
2011-05-31
Completion date
2012-12-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCG

Keywords

hcg

Brief summary

Subjects are female patients, randomized to HCG group or placebo group, during a prospective trial, in order to determine the significance, if any, of HCG on maintaining muscle mass during a very low calorie diet in order to demonstrate the potential significance of HCG administration on preserving lean body mass while losing weight.

Detailed description

Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an 18 month period. Exclusion criteria included thyroid conditions or prior significant medical history. Patients were randomized to receive daily subcutaneous injections of either hCG (200-300IU) or saline (placebo). All were placed on a VLCD resembling a protein-sparing modified fast. The caloric intake was between 500 and 600 calories, with 50% protein and 50% complex carbohydrates consisting mostly of fruits and vegetables. Measured parameters: weight, body composition via bio-impedance, blood pressure, and blood labs. A subset also underwent weekly electrocardiograms (EKG).

Interventions

DRUGHuman Chorionic Gonadotropin

The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.

DRUGPlacebo
OTHERLow calorie diet

Sponsors

Dr. Emma's Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Body Mass Index (BMI) greater than 30, * Female, * good health

Exclusion criteria

* complex medical history, * thyroid disease, * BMI less than 30, * psychological instability or history of eating disorder

Design outcomes

Primary

MeasureTime frameDescription
Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.30 daysComparison of weight loss between the experimental and control group

Secondary

MeasureTime frameDescription
Muscle loss comparison between HCG and placebo group during a very low calorie diet.30 daysLean body mass and muscle mass readings used to compare between experimental and control group.

Other

MeasureTime frameDescription
Fat loss comparison between HCG and placebo groups during a very low calorie diet.30 daysFat mass readings used to compare between experimental and control groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026