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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HCG Drug: Human Chorionic Gonadotropin Drug: Placebo Other: Low calorie diet Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
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.
 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

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.
 Drug: Placebo
Other: Low calorie diet


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427529


Locations
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United States, New Jersey
Dr. Emma's Corporation
Colts Neck, New Jersey, United States, 07722
Sponsors and Collaborators
Dr. Emma's Corporation
More Information
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Responsible Party: Dr. Emma's Corporation
ClinicalTrials.gov Identifier: NCT02427529    
Other Study ID Numbers: 053111
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Dr. Emma's Corporation:
hcg
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs