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

HCG Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427529
• Other study ID #: 053111
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 23, 2015
• Last updated: April 27, 2015
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Dr. Emma's Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• HCG

Intervention

Drug:
• Human Chorionic Gonadotropin
The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
• Placebo

Other:
• Low calorie diet

Locations

Country	Name	City	State
United States	Dr. Emma's Corporation	Colts Neck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Emma's Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fat loss comparison between HCG and placebo groups during a very low calorie diet.	Fat mass readings used to compare between experimental and control groups.	30 days	No
Primary	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	30 days	No
Secondary	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.	30 days	No