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

April 27, 2015 updated by: Dr. Emma's Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCG Group
This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.
Drug: Human Chorionic Gonadotropin
The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
Other Names:
  • Pregnyl, Novarel
Other: Low calorie diet
Placebo Comparator: Saline/Placebo
This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
Drug: Placebo
Other: Low calorie diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
Time Frame: 30 days
Comparison of weight loss between the experimental and control group
30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat loss comparison between HCG and placebo groups during a very low calorie diet.
Time Frame: 30 days
Fat mass readings used to compare between experimental and control groups.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Emma's Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 053111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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