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

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ClinicalTrials.gov Identifier: NCT02427529
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Emma's Corporation

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE April 28, 2015
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Official Title  ICMJE Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Brief 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE HCG
Intervention  ICMJE
  • 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 Name: Pregnyl, Novarel
  • Drug: Placebo
  • Other: Low calorie diet
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Human Chorionic Gonadotropin
    • 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.
    Interventions:
    • Drug: Placebo
    • Other: Low calorie diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
59
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427529
Other Study ID Numbers  ICMJE 053111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Emma's Corporation
Study Sponsor  ICMJE Dr. Emma's Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr. Emma's Corporation
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP