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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCG Group | Experimental | This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day. |
|
| Saline/Placebo | Placebo Comparator | This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Chorionic Gonadotropin | Drug | The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fat loss comparison between HCG and placebo groups during a very low calorie diet. | Fat mass readings used to compare between experimental and control groups. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Emma's Corporation | Colts Neck | New Jersey | 07722 | United States |
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| ID | Term |
|---|---|
| C538388 | Hypertrichosis congenital generalized X-linked |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug |
|
| Low calorie diet | Other |
|
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |