A Nutritional Intervention in Police Officers

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

Study Overview

• Status: Suspended
• Conditions: Diabetes Mellitus, Type 2; Overweight; Blood Pressure
• Intervention / Treatment: Dietary supplement: Plant-based diet; Dietary supplement: Control Group

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Physicians Committee for Responsible Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Plant-based diet; Weekly instructions will be given to the participants in the intervention group about following vegan diet.; Other Names: Vegan Group
Active Comparator: Control Group; The control group will follow an unrestricted diet with no instruction.	Dietary supplement: Control Group; Unrestricted diet with no instruction.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	body weight will be measured to the nearest 0.1 kg, using a digital scale.	Changes in body weight from Baseline at 14 weeks
Plasma lipid concentrations	will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations.	Changes in plasma lipid concentrations from Baseline at 14 weeks
Blood pressure	Blood pressure will be measured at each assessment	Changes in blood pressure from Baseline at 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life and Mood	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.	Change in quality of life from Baseline at 4 months

Collaborators and Investigators

• Sponsor: Physicians Committee for Responsible Medicine
• Collaborators: Metropolitan Police Department of Washington, D.C.
• Investigators: Principal Investigator: Neal D Barnard, M.D., President

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimated): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Diet, Vegetarian; Diet, Fat-Restricted; Glycemic Index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: PCRM MPD