Blood Pressure, Diabetes Mellitus, Type 2, Overweight
Conditions
Keywords
Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life, Glycemic Index
Brief summary
The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTPlant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
DIETARY_SUPPLEMENTControl Group
Unrestricted diet with no instruction.
Sponsors
Physicians Committee for Responsible Medicine
Metropolitan Police Department of Washington, D.C.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women at least 18 years 2. Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes 3. Currently an employee of the Metropolitan Police Department of the District of Columbia 4. Ability and willingness to participate in all components of the study 5. A willingness to be randomly assigned to either study group
Exclusion criteria
1. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 2. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) 3. Pregnancy 4. Unstable medical or psychiatric illness 5. Likely to be disruptive in group sessions (as determined by research staff) 6. Already following a low-fat, vegan diet 7. Lack of English fluency 8. Inability or unwillingness to participate in all components of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Changes in body weight from Baseline at 14 weeks | body weight will be measured to the nearest 0.1 kg, using a digital scale. |
| Plasma lipid concentrations | Changes in plasma lipid concentrations from Baseline at 14 weeks | will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations. |
| Blood pressure | Changes in blood pressure from Baseline at 14 weeks | Blood pressure will be measured at each assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life and Mood | Change in quality of life from Baseline at 4 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNeal D Barnard, M.D.
President
Outcome results
None listed