Clinical trial NCT02651480: A Nutritional Intervention in Police Officers
Official title: A Nutritional Intervention in Police Officers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Overweight
Blood Pressure
Diabetes Mellitus, Type 2
Keywords: Diet, Vegetarian
Diet, Fat-Restricted
Quality of Life
Glycemic Index
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
Collaborators: name: Metropolitan Police Department of Washington, D.C.
First posted: 2016-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: Changes in body weight from Baseline at 14 weeks
measure: Plasma lipid concentrations
timeFrame: Changes in plasma lipid concentrations from Baseline at 14 weeks
measure: Blood pressure
timeFrame: Changes in blood pressure from Baseline at 14 weeks
Secondary outcomes:
measure: Quality of Life and Mood
timeFrame: Change in quality of life from Baseline at 4 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: President
name: Neal D Barnard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: