OverweightNCT02651480
A Nutritional Intervention in Police Officers
A study testing Plant-based diet in people with Overweight and Blood Pressure, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Overweight, Blood Pressure, Diabetes Mellitus, Type 2
- What is being tested?
- Plant-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016
About this study
The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.
Read the 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).
- Conditions
- Overweight, Blood Pressure, Diabetes Mellitus, Type 2
- Being tested
- Plant-based diet, Control Group
- Keywords
- Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life, Glycemic Index
- Medical subject headings
- Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietDietary supplement
Also called Vegan Group
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Control GroupDietary supplement
Also called Control
Unrestricted diet with no instruction.
| Study group | Role | What they receive |
|---|---|---|
| Vegan Group | Experimental | 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. Receives: Dietary Supplement: Plant-based diet |
| Control Group | Active comparator | The control group will follow an unrestricted diet with no instruction. Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
body weight will be measured to the nearest 0.1 kg, using a digital scale.
Measured: 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.
Measured: Changes in plasma lipid concentrations from Baseline at 14 weeks
Blood pressure
Blood pressure will be measured at each assessment
Measured: Changes in blood pressure from Baseline at 14 weeks
Secondary outcomes (1)
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.
Measured: Change in quality of life from Baseline at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2026
- Study completionSep 2026
Why it stopped: Sponsor put plans on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan Police Department of Washington, D.C.
- Responsible party
- Sponsor
- Investigators
- Neal D Barnard, M.D., Principal investigator, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651480
- Sponsor's protocol ID
- PCRM MPD
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2016
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Intervention in Police Officers
- ClinicalTrials.gov ID
- NCT02651480
- Acronym / sponsor ID
- PCRM MPD
- Conditions
- Overweight, Blood Pressure, Diabetes Mellitus, Type 2
- Keywords
- Diet, Vegetarian, Diet, Fat-Restricted, Quality of Life, Glycemic Index
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor put plans on hold
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Collaborators
- Metropolitan Police Department of Washington, D.C.
- Study start
- Feb 2016
- Primary completion
- Sep 2026 (actual)
- Study completion
- Sep 2026 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Group | Experimental | Dietary Supplement: Plant-based dietParticipants 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. |
| Control Group | Active comparator | Dietary Supplement: Control GroupThe control group will follow an unrestricted diet with no instruction. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based dietAlso: Vegan GroupWeekly instructions will be given to the participants in the intervention group about following vegan diet. | Dietary supplement | Vegan Group |
| Control GroupAlso: ControlUnrestricted diet with no instruction. | Dietary supplement | Control Group |
Primary outcome
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.
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.
Blood pressure
Time frame: Changes in blood pressure from Baseline at 14 weeks
Blood pressure will be measured at each assessment
1 secondary outcome
Quality of Life and Mood
Time frame: Change in quality of life from Baseline at 4 months
Results and safety
The study was stopped early (reason given: Sponsor put plans on hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal D Barnard, M.D. principal investigator
President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet in people with Overweight and Blood Pressure, run by Physicians Committee for Responsible Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor put plans on hold). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Changes in body weight from Baseline at 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.