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A Nutritional Intervention in Police Officers

P

Physicians Committee for Responsible Medicine

Status

Suspended

Conditions

Overweight
Diabetes Mellitus, Type 2
Blood Pressure

Treatments

Dietary Supplement: Control Group
Dietary Supplement: Plant-based diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02651480
PCRM MPD

Details and patient eligibility

About

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

Full 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).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Vegan Group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Plant-based diet
Control Group
Active Comparator group
Description:
The control group will follow an unrestricted diet with no instruction.
Treatment:
Dietary Supplement: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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