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

Phase 1

Completed

• Conditions: HCG
• Interventions: Drug: Placebo; Drug: Human Chorionic Gonadotropin; Other: Low calorie diet

• Registration Number: NCT02427529
• Lead Sponsor: Dr. Emma's Corporation

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).

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Study First Posted: 2015-04-28
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline/Placebo	Low calorie diet	This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
HCG Group	Low calorie diet	This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.
Saline/Placebo	Placebo	This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
HCG Group	Human Chorionic Gonadotropin	This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.

Primary Outcome Measures

Name	Time	Method
Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.	30 days	Comparison of weight loss between the experimental and control group

Secondary Outcome Measures

Name	Time	Method
Muscle loss comparison between HCG and placebo group during a very low calorie diet.	30 days	Lean body mass and muscle mass readings used to compare between experimental and control group.

Trial Locations

Locations (1)

Dr. Emma's Corporation; 🇺🇸 Colts Neck, New Jersey, United States