A Nutritional Intervention in Police Officers

Physicians Committee for Responsible Medicine

Status: Suspended

Conditions: Overweight; Diabetes Mellitus, Type 2; Blood Pressure

Treatments: Dietary Supplement: Control Group; Dietary Supplement: Plant-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02651480

PCRM MPD

Details and patient eligibility

About

The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Vegan Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Plant-based diet

Control Group

Active Comparator group

Description:

The control group will follow an unrestricted diet with no instruction.

Treatment:

Dietary Supplement: Control Group