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

Arm | Intervention/treatment |
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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.
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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.
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Drug: Placebo Other: Low calorie diet |
- 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
- 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.
- 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.

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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 |
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

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
United States, New Jersey | |
Dr. Emma's Corporation | |
Colts Neck, New Jersey, United States, 07722 |
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 |
hcg |
Chorionic Gonadotropin Reproductive Control Agents Physiological Effects of Drugs |