A Nutritional Intervention in Police Officers

Not Applicable

Suspended

• Conditions: Blood Pressure; Overweight; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Control Group; Dietary Supplement: Plant-based diet

• Registration Number: NCT02651480
• Lead Sponsor: Physicians Committee for Responsible Medicine

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).

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	The control group will follow an unrestricted diet with no instruction.
Vegan Group	Plant-based diet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States