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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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HCG

Intervention / Treatment
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* Drug: Human Chorionic Gonadotropin
* Drug: Placebo
* Other: Low calorie diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCG Group<br>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<br>* The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.<br>* Other names: Pregnyl, Novarel;Other: Low calorie diet<br> <br> |
| Placebo Comparator: Saline/Placebo<br>This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day. | Drug: Placebo<br> <br> Other: Low calorie diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet. | Comparison of weight loss between the experimental and control group | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle loss comparison between HCG and placebo group during a very low calorie diet. | Lean body mass and muscle mass readings used to compare between experimental and control group. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hcg