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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
Dr. Emma's Corporation
Colts Neck, New Jersey, United States
Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
Comparison of weight loss between the experimental and control group
Time frame: 30 days
Muscle loss comparison between HCG and placebo group during a very low calorie diet.
Lean body mass and muscle mass readings used to compare between experimental and control group.
Time frame: 30 days
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