Expired Study
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Colts Neck, New Jersey 07722


Purpose:

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.


Study summary:

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).


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


Study is Available At:


Original ID:

053111


NCT ID:

NCT02427529


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dr. Emma's Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

59


Enrollment Type:

Actual


Study Dates

Start Date:May 2011
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 27, 2015
First Received Date:April 23, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Muscle loss comparison between HCG and placebo group during a very low calorie diet.
Time Frame:30 days
Safety Issues:False
Description:Lean body mass and muscle mass readings used to compare between experimental and control group.
Outcome Type:Primary Outcome
Measure:Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
Time Frame:30 days
Safety Issues:False
Description:Comparison of weight loss between the experimental and control group

Study Interventions

Intervention Type:Drug
Name:Human Chorionic Gonadotropin
Description:The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
Arm Name:HCG Group
Other Name:Pregnyl, Novarel
Intervention Type:Drug
Name:Placebo
Arm Name:Saline/Placebo
Intervention Type:Other
Name:Low calorie diet
Arm Name:HCG Group

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Saline/Placebo
Description:This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
Study Arm Type:Experimental
Arm Name:HCG Group
Description:This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dr. Emma's Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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