A Nutritional Intervention in Police Officers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Nutritional Intervention in Police Officers

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02651480
• Other study ID #: PCRM MPD
• Status: Suspended
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Diabetes Mellitus, Type 2
• Overweight

Intervention

Dietary Supplement:
• Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
• Control Group
Unrestricted diet with no instruction.

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine	Metropolitan Police Department of Washington, D.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood pressure	Blood pressure will be measured at each assessment	Changes in blood pressure from Baseline at 14 weeks
Secondary	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