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Type 2 DiabetesPOWERNCT07095543

Plant-Based Online Weight Loss Through Education and Resources Program and Study

A study testing Low-fat, vegan diet in people with Type 2 Diabetes and Overweight and Obese Adults, run by Physicians Committee for Responsible Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Overweight and Obese Adults
What is being tested?
Low-fat, vegan diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
2 Jan 2026to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • U.S. men and women meeting the age of majority, defined as follows:
  • Age 19 or older in Nebraska and Alabama. Age 21 or older in Puerto Rico. Age 18 or older in all other states.
  • Able and willing to travel to Washington DC for a dual-energy х-rау absorptiometry (DXA) scans before and after the program.
  • Able and willing to complete laboratory assessments at a local LabCorp facility before and after the program.
  • Able and willing to participate in all components of the study.
  • BMI of 25 or more (23 or more in persons of Asian origin).
  • Access to the internet.
  • English fluency.

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.
  • Inability to maintain medication regimen as prescribed by personal healthcare provider.
  • Current or expected use of any weight loss medication during the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
  • Use of any weight loss medication within the 12 months preceding the study period, including but not limited to, glucagon-like peptide-1 (GLP-1) receptor agonists and combination GLP-1 receptor/glucose-dependent insulinotropic polypeptide (GIP) agonists.
Show all 9Show fewer
  • Body weight greater than 182 kg.
  • Current diagnosis of eating disorder.
  • Intention to follow another weight loss method during the study period.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanita Rahman, MD, DipACLM contact

202-527-7500

vrahman@pcrm.org

Shannon Menhardt, MS, RD contact

202-527-7500

smenhardt@pcrm.org

United States1 site, 1 recruiting
  • Physicians Committee for Responsible Medicine

    Washington D.C., District of Columbia, 20016

    Vanita Rahman, MD, 202-527-7500, vrahman@pcrm.org

    Recruiting

Other trials in United States

About this study

Official title: Feasibility, Implementation, and Efficacy of a Plant-based Online Weight Loss Through Education and Resources Program and Study (POWER Study)

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will meet with a physician and a registered dietitian once a week to learn about a plant-based diet and receive support and practical help in making the dietary changes. Body composition, blood sugar control, cholesterol levels, and food costs will be measured at the start and end of the study.

Read the detailed description

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will participate in weekly physician- and dietitian-lead group classes and will receive education about a plant-based diet as well as support and practical tips for implementing the dietary changes. Participants will receive baseline and 12 week assessments including a DXA scan to assess body composition, HbA1c, lipid panel, and a food cost analysis.

Being tested
Low-fat, vegan diet
Keywords
Plant-based diet, Vegan diet, type 2 diabetes, Weight loss, Overweight, Obesity, Cholesterol
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Weight Loss, Obesity

What participants receive

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

  • Low-fat, vegan dietBehavioural

    All participants will be asked to follow a low-fat vegan diet for the duration of the study. Participants will attend weekly classes where they we receive education and support.

Study groups in NCT07095543
Study groupRoleWhat they receive
Low-fat, vegan dietExperimentalAll participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group.
Receives: Behavioral: Low-fat, vegan diet

What is being measured

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

  1. The feasibility of an online plant-based weight loss program in the community setting.

    Feasibility will be assessed by the number of total participants that enroll in the program and complete both baseline and final assessments.

    Measured: From baseline to the end of the intervention at 12 weeks.

Secondary outcomes (4)
  1. Changes in glycated hemoglobin.

    A1c will be measured using standard methods.

    Measured: From baseline to the end of the intervention at 12 weeks.

  2. Changes in total and LDL cholesterol levels.

    Total and LDL cholesterol levels will be measured using standard methods.

    Measured: From baseline to the end of the intervention at 12 weeks.

  3. Changes in 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: From baseline to the end of the intervention at 12 weeks.

  4. Food costs of a baseline diet and a low-fat plant-based diet.

    Study participants will be asked to provide a food consumption record of three consecutive days (including two weekdays and one weekend day). Participants will be asked to include the specific brands, portions, names of retailers and restaurants where the food was purchased. A study team member will review the food record with the participants. We will then calculate the total cost of the food consumed during the 3-day period using cost data from the retailers' and restaurants' websites or by calling the specific restaurants and retailers.

    Measured: From baseline to the end of the intervention at 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 posted31 Jul 2025
  2. Study start2 Jan 2026
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

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
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07095543
Sponsor's protocol ID
Pro00087270
Acronym
POWER
Status last verified
Sep 2026
First submitted
15 Jul 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kahleova H, Sutton M, Maracine C, Nichols D, Monsivais P, Holubkov R, Barnard ND. Food Costs of a Low-Fat Vegan Diet vs a Mediterranean Diet: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445784. doi: 10.1001/jamanetworkopen.2024.45784.

    PubMed 39556398
  • Kahleova H, Sutton M, Maracine C, Nichols D, Monsivais P, Holubkov R, Barnard ND. Vegan Diet and Food Costs Among Adults With Overweight: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332106. doi: 10.1001/jamanetworkopen.2023.32106.

    PubMed 37669055
  • Stanford J, Zuck M, Stefoska-Needham A, Charlton K, Lambert K. Acceptability of Plant-Based Diets for People with Chronic Kidney Disease: Perspectives of Renal Dietitians. Nutrients. 2022 Jan 4;14(1):216. doi: 10.3390/nu14010216.

    PubMed 35011091
  • 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
  • Emamat H, Jamshidi A, Farhadi A, Ghalandari H, Ghasemi M, Tangestani H. The association between the visceral to subcutaneous abdominal fat ratio and the risk of cardiovascular diseases: a systematic review. BMC Public Health. 2024 Jul 9;24(1):1827. doi: 10.1186/s12889-024-19358-0.

    PubMed 38982435
  • Yokoyama Y, Levin SM, Barnard ND. Association between plant-based diets and plasma lipids: a systematic review and meta-analysis. Nutr Rev. 2017 Sep 1;75(9):683-698. doi: 10.1093/nutrit/nux030.

    PubMed 28938794
  • Kahleova H, Petersen KF, Shulman GI, Alwarith J, Rembert E, Tura A, Hill M, Holubkov R, Barnard ND. Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025454. doi: 10.1001/jamanetworkopen.2020.25454.

    PubMed 33252690
  • Kahleova H, Tura A, Hill M, Holubkov R, Barnard ND. A Plant-Based Dietary Intervention Improves Beta-Cell Function and Insulin Resistance in Overweight Adults: A 16-Week Randomized Clinical Trial. Nutrients. 2018 Feb 9;10(2):189. doi: 10.3390/nu10020189.

    PubMed 29425120
  • Campbell TM, Campbell EK, Attia J, Ventura K, Mathews T, Chhabra KH, Blanchard LM, Wixom N, Faniyan TS, Peterson DR, Harrington DK, Wittlin SD. The acute effects of a DASH diet and whole food, plant-based diet on insulin requirements and related cardiometabolic markers in individuals with insulin-treated type 2 diabetes. Diabetes Res Clin Pract. 2023 Aug;202:110814. doi: 10.1016/j.diabres.2023.110814. Epub 2023 Jul 5.

    PubMed 37419391
  • Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

    PubMed 16873779
  • Gwira JA, Fryar CD, Gu Q. Prevalence of Total, Diagnosed, and Undiagnosed Diabetes in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Nov;(516):CS354814. doi: 10.15620/cdc/165794.

    PubMed 40085919
  • Barnard ND, Alwarith J, Rembert E, Brandon L, Nguyen M, Goergen A, Horne T, do Nascimento GF, Lakkadi K, Tura A, Holubkov R, Kahleova H. A Mediterranean Diet and Low-Fat Vegan Diet to Improve Body Weight and Cardiometabolic Risk Factors: A Randomized, Cross-over Trial. J Am Nutr Assoc. 2022 Feb;41(2):127-139. doi: 10.1080/07315724.2020.1869625. Epub 2021 Feb 5.

    PubMed 33544066
  • Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju ShN, Wormser D, Gao P, Kaptoge S, Berrington de Gonzalez A, Cairns BJ, Huxley R, Jackson ChL, Joshy G, Lewington S, Manson JE, Murphy N, Patel AV, Samet JM, Woodward M, Zheng W, Zhou M, Bansal N, Barricarte A, Carter B, Cerhan JR, Smith GD, Fang X, Franco OH, Green J, Halsey J, Hildebrand JS, Jung KJ, Korda RJ, McLerran DF, Moore SC, O'Keeffe LM, Paige E, Ramond A, Reeves GK, Rolland B, Sacerdote C, Sattar N, Sofianopoulou E, Stevens J, Thun M, Ueshima H, Yang L, Yun YD, Willeit P, Banks E, Beral V, Chen Zh, Gapstur SM, Gunter MJ, Hartge P, Jee SH, Lam TH, Peto R, Potter JD, Willett WC, Thompson SG, Danesh J, Hu FB. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016 Aug 20;388(10046):776-86. doi: 10.1016/S0140-6736(16)30175-1. Epub 2016 Jul 13.

    PubMed 27423262
  • Kivimaki M, Kuosma E, Ferrie JE, Luukkonen R, Nyberg ST, Alfredsson L, Batty GD, Brunner EJ, Fransson E, Goldberg M, Knutsson A, Koskenvuo M, Nordin M, Oksanen T, Pentti J, Rugulies R, Shipley MJ, Singh-Manoux A, Steptoe A, Suominen SB, Theorell T, Vahtera J, Virtanen M, Westerholm P, Westerlund H, Zins M, Hamer M, Bell JA, Tabak AG, Jokela M. Overweight, obesity, and risk of cardiometabolic multimorbidity: pooled analysis of individual-level data for 120 813 adults from 16 cohort studies from the USA and Europe. Lancet Public Health. 2017 May 19;2(6):e277-e285. doi: 10.1016/S2468-2667(17)30074-9. eCollection 2017 Jun.

    PubMed 28626830
  • Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Sep;(508):10.15620/cdc/159281. doi: 10.15620/cdc/159281.

    PubMed 39808758

Questions about this trial

What is this clinical trial studying?

A study testing Low-fat, vegan diet in people with Type 2 Diabetes and Overweight and Obese Adults, 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 8 inclusion and 9 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: looking for participants now, 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanita Rahman, MD, DipACLM (202-527-7500, vrahman@pcrm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The feasibility of an online plant-based weight loss program in the community setting. (time frame: From baseline to the end of the intervention at 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 NCT07095543, which also lists 15 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; AzTrials last refreshed its copy on 26 Oct 2026.

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