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OpenTrials
Completed

NCT Number: NCT02427529

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

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.

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Key information

Conditions

hCG Hypertrichosis congenital generalized X-linked

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr. Emma's Corporation

Colts Neck, New Jersey, 07722, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Chorionic Gonadotropin

Drug

The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.

Other names: Pregnyl, Novarel

Placebo

Drug

low calorie diet

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dr. Emma's Corporation

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 28, 2015
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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