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

Dr. Emma's Corporation

Status and phase: Completed; Phase 2; Phase 1

Conditions: HCG

Treatments: Drug: Human Chorionic Gonadotropin; Drug: Placebo; Other: Low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02427529

053111

Details and patient eligibility

About

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.

Full 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).

Enrollment: 59 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

59 participants in 2 patient groups, including a placebo group

HCG Group

Experimental group

Description:

This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.

Treatment:

Drug: Human Chorionic Gonadotropin

Other: Low calorie diet

Saline/Placebo

Placebo Comparator group

Description:

This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.

Treatment:

Drug: Placebo

Other: Low calorie diet