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

Information source: Dr. Emma's Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HCG

Intervention: Human Chorionic Gonadotropin (Drug); Placebo (Drug); Low calorie diet (Other)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Dr. Emma's Corporation

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.

Secondary outcome: Muscle loss comparison between HCG and placebo group during a very low calorie diet.

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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Dr. Emma's Corporation, Colts Neck, New Jersey 07722, United States
Additional Information

Starting date: May 2011
Last updated: April 27, 2015

Page last updated: August 23, 2015

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