NCT02427529

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Dr. Emma's Corporation · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• HCG

Interventions

Type	Name	Description
DRUG	Human Chorionic Gonadotropin	The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
DRUG	Placebo
OTHER	Low calorie diet

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2015-04-28
• Last updated: 2015-04-28

Locations

1 site across 1 country: United States