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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South Beach Diet™ products compared to a traditional calorie restricted diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| South Beach Diet™ with SBD™ Products | Active Comparator |
| |
| South Beach Diet™ alone | Active Comparator |
| |
| Calorie restricted diet w/ SBD™ Products | Active Comparator |
| |
| Calorie Restricted Diet alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| South Beach Diet™ with South Beach Diet™ Products | Behavioral |
| ||
| South Beach Diet™ |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from baseline to week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the satiety response to the individual diets | 24 weeks | |
| Analyze circumference measurements & body composition; blood glucose, HbA1c, insulin, lipid profile, blood pressure & questionnaire responses on food cravings and quality of life | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicus Research | Northridge | California | 91325 | United States | ||
| SIBR Research |
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| Behavioral |
|
| Calorie restricted diet with South Beach Diet™ Products | Behavioral |
|
| Calorie Restricted Diet | Behavioral |
|
| Bradenton |
| Florida |
| 34205 |
| United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Chase Wellness & Research Center | Virginia Beach | Virginia | 23455 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D000073600 | Diet, High-Protein |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D002149 | Energy Intake |
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