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Sponsor put plans on hold
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| Name | Class |
|---|---|
| Metropolitan Police Department of Washington, D.C. | UNKNOWN |
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The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.
This study tests the hypotheses that a low-fat, plant-based (vegan) diet improves body weight, plasma lipid concentrations, blood pressure, and, in individuals with type 2 diabetes, glycemic control, that a low-fat, plant-based diet improves health-related quality of life as measured by the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36), and that a low-fat, plant-based diet improves mood, as measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegan Group | Experimental | Participants in the intervention group will follow a low-fat, plant-based diet for 14 weeks, and will attend nutrition classes in the form of a weekly support group. |
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| Control Group | Active Comparator | The control group will follow an unrestricted diet with no instruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based diet | Dietary Supplement | Weekly instructions will be given to the participants in the intervention group about following vegan diet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | body weight will be measured to the nearest 0.1 kg, using a digital scale. | Changes in body weight from Baseline at 14 weeks |
| Plasma lipid concentrations | will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations. | Changes in plasma lipid concentrations from Baseline at 14 weeks |
| Blood pressure | Blood pressure will be measured at each assessment | Changes in blood pressure from Baseline at 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life and Mood | Measured by a Modified Health Assessment Questionnaire (MHAQ). The questionnaire measures the difficulty level of performing 8 different activities. A score of 0 = the activity can be performed without difficulty. A score of 3 = the activity cannot be performed. The MHAQ is calculated as the average of these scores. | Change in quality of life from Baseline at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal D Barnard, M.D. | President | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Control Group | Dietary Supplement | Unrestricted diet with no instruction. |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |