A Nutritional Intervention in Police Officers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Overweight Blood Pressure Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Vegan Group

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.

Group Type EXPERIMENTAL

Plant-based diet

Intervention Type DIETARY_SUPPLEMENT

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Control Group

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type DIETARY_SUPPLEMENT

Unrestricted diet with no instruction.

Interventions

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Plant-based diet

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Intervention Type DIETARY_SUPPLEMENT

Control Group

Unrestricted diet with no instruction.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vegan Group Control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No