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OpenTrials
Terminated

NCT Number: NCT02651480

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.

Why the study stopped: Sponsor put plans on hold
Terminated

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women at least 18 years
  • 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
  • Currently an employee of the Metropolitan Police Department of the District of Columbia
  • Ability and willingness to participate in all components of the study
  • A willingness to be randomly assigned to either study group

Exclusion criteria

  • 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
  • Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  • Pregnancy
  • Unstable medical or psychiatric illness
  • Likely to be disruptive in group sessions (as determined by research staff)
  • Already following a low-fat, vegan diet
  • Lack of English fluency
  • Inability or unwillingness to participate in all components of the study

Treatment and study plan

Plant-based diet

Dietary Supplement

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

Other names: Vegan Group

Control group

Dietary Supplement

Unrestricted diet with no instruction.

Other names: Control

Primary outcomes

  1. Body Weight

    Time frame: Changes in body weight from Baseline at 14 weeks

    body weight will be measured to the nearest 0.1 kg, using a digital scale.

  2. Plasma lipid concentrations

    Time frame: 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.

  3. Blood pressure

    Time frame: Changes in blood pressure from Baseline at 14 weeks

    Blood pressure will be measured at each assessment

Secondary outcomes

  1. Quality of Life and Mood

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Collaborators

  • Metropolitan Police Department of Washington, D.C.

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2016
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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