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| Name | Class |
|---|---|
| Curves International | INDUSTRY |
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The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.
The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive CIQ plus High Carbohydrate Diet | Active Comparator | Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet |
|
| Positive CIQ plus High Protein Diet | Active Comparator | Positive Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet |
|
| Negative CIQ plus High Carbohydrate Diet | Active Comparator | Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 30% carbohydrate, 45% protein, 25% fat diet |
|
| Negative CIQ plus High Protein Diet | Active Comparator | Negative Carbohydrate Intolerance Questionnaire (CIQ) plus 20% carbohydrate, 45% protein, 35% fat diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive CIQ plus High Carbohydrate Diet | Other | Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of diet selection on physical activity patterns changes (steps per day) | 24 weeks | |
| Effects of diet selection on body weight changes (pounds) | 24 weeks | |
| Effects of diet selection on hip/waist ratio changes (inches) | 24 weeks | |
| Effects of diet selection on Resting Energy Expenditure (REE) changes (calories per day) | 24 weeks | |
| Effects of diet selection on Blood Pressure (BP) changes (mmHG) | 24 weeks | |
| Effects of diet selection on Heart Rate (HR) changes (beats per minute) | 24 weeks | |
| Effects of diet selection on body composition (DXA) changes (percent fat mass) | 24 weeks | |
| Effects of diet selection on Bioelectrical Impedance Analysis (BIA) changes (flow impedance) | 24 weeks | |
| Effects of diet selection on a chemistry-15 blood panel changes | 24 weeks | |
| Effects of diet selection on a cell blood count (CBC) blood panel changes | 24 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of diet selection on maximal cardiopulmonary capacity changes (ml/kg/min) | 24 weeks | |
| Effects of diet selection on muscular strength through a 1 repetition maximum (1 RM) test | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
The eligibility criteria were at the request of the study sponsor.
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Kreider, PhD | Texas A&M University | Principal Investigator |
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| Positive CIQ plus High Protein Diet | Other | Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet |
|
| Negative CIQ plus High Carbohydrate Diet | Other | Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet |
|
| Negative CIQ plus High Protein Diet | Other | Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet |
|
| Effects of diet selection on lipid panel changes |
| 24 weeks |
| Effects of diet selection on muscular endurance through a maximal repetition test |
| 24 weeks |
| Effects of diet selection on gene expression changes | 24 weeks |
| Effects of diet selection on DNA methylation changes | 24 weeks |
| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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