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Weight LossNCT04091516

Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

A study testing Low-fat plant-based diet in people with Weight Loss and Blood Pressure, run by Physicians Committee for Responsible Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Weight Loss, Blood Pressure, Lipid Disorder
What is being tested?
Low-fat plant-based diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
30 Aug 2019to 31 Jul 2020
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women age ≥18 years of age

Who cannot join

  • Use of recreational drugs in the past 6 months
  • Pregnancy or intention to become pregnant during the study period, as verified by self-report
  • Unstable medical or psychiatric illness
  • Lack of English fluency
  • Inability to maintain current medication regimen
  • Inability or unwillingness to participate in all components of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barnard Medical Center

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: The Feasibility, Implementation and Efficacy of a Plant-Based Weight-Loss Program in a Practice-Based Setting

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

Read the detailed description

This will be a prospective interventional study to evaluate the feasibility, implementation and efficacy of 12-week plant-based, weight-loss program that is carried out in an office setting and is open to participation to the general public via local print and online advertising or whichever methods apply. The program will include weekly education and support, and assessment of blood pressure, lipids, hemoglobin A1c, and body composition before and after starting the program. The price of the program, $645, will cover the costs of weekly education, blood pressure check, laboratory testing and body composition analysis.

Being tested
Low-fat plant-based diet
Keywords
weight loss, body composition, lipids, hemoglobin A1c, blood pressure
Medical subject headings
Weight Loss, Lipid Metabolism Disorders, Prediabetic State, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-fat plant-based dietBehavioural

    Participants will follow a diet that consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.

Study groups in NCT04091516
Study groupRoleWhat they receive
Low-fat plant-based dietOtherFor 12 weeks, participants will follow a diet comprised of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.
Receives: Behavioral: Low-fat plant-based diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    With participants wearing light, indoor clothing but without shoes, body weight will be measured to the nearest 0.1 kg, using a digital scale. Body weight will also be assessed at each weekly session, but only data from the week 1 (pre-program) and week 12 (post-program) will be included in the analysis.

    Measured: Change from baseline to 12 weeks

Secondary outcomes (4)

  1. Blood pressure

    Blood pressure will be measured using an automated oscillometric device.

    Measured: Change from baseline to 12 weeks

  2. Plasma cholesterol and triacylglycerol concentrations

    Will be measured using standard methods.

    Measured: Change from baseline to 12 weeks

  3. hemoglobin A1c

    will be measured using standard methods.

    Measured: Change from baseline to 12 weeks

  4. Body Composition

    Body composition will be measured by dual energy x-ray absorptometry (Lunar iDXA, GE Healthcare; Madison, WI) with Encore® 2005 v.9.15.010 software. The iDXA can measure body composition with low x-ray exposure and short scanning time. The iDXA unit will be calibrated daily using the GE Lunar calibration phantom, and a trained operator will perform all scans following standard protocol for participant positioning. The iDXA is equipped with the CoreScan module (GE Healthcare, Madison, WI), which can also provide an estimate of visceral adipose tissue volume and mass.

    Measured: Change from baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start30 Aug 2019
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective interventional study without a control group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091516
Sponsor's protocol ID
Pro00037092
Status last verified
Sep 2026
First submitted
13 Sep 2019
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will make individual data available to other researchers upon request

Publications

  • Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.

    PubMed 19351712

  • Barnard ND, Levin SM, Yokoyama Y. A systematic review and meta-analysis of changes in body weight in clinical trials of vegetarian diets. J Acad Nutr Diet. 2015 Jun;115(6):954-69. doi: 10.1016/j.jand.2014.11.016. Epub 2015 Jan 22.

    PubMed 25620754

  • Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31

  • Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.

  • American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.

    PubMed 12778049

  • Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004.

    PubMed 15286527

  • Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.

    PubMed 19167953

  • Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.

    PubMed 7842153

  • Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.

  • U.S. Census Bureau. Quick Facts. District of Columbia. Internet: http://www.census.gov/quickfacts/table/RHI125215/11, accessed August 22, 2016.

Questions about this trial

What is this clinical trial studying?

A study testing Low-fat plant-based diet in people with Weight Loss 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 1 inclusion and 6 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Weight loss (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091516, which also lists 10 linked publications.

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.

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