ClinicalTrials.gg
RecruitingNCT07095543POWERUpdated Sep 17, 2026

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

An interventional study of Low-fat, vegan diet in Type 2 Diabetes and Overweight and Obese Adults, sponsored by Physicians Committee for Responsible Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Diabetes Mellitus, Type 2 by Physicians Committee for Responsible Medicine — 2 open to participants now, 2 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Physicians Committee for Responsible Medicine.

Planned enrollment
3rd of 10
100 · median 38
Started
2026
the only one that year
No phase
10 of 10
2 open now
Registered
10th of 10
by date

Among the 10 studies in Diabetes Mellitus, Type 2 by Physicians Committee for Responsible Medicine, this one is the 3rd largest by planned enrollment, is the only one that started in 2026, is one of 10 with no phase, and was the 10th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

2 of the 10 studies in Diabetes Mellitus, Type 2 by Physicians Committee for Responsible Medicine are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Diabetes Mellitus, Type 2 by Physicians Committee for Responsible Medicine, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Type 2 Diabetes
  • Overweight and Obese Adults

Keywords

  • Plant-based diet
  • Vegan diet
  • type 2 diabetes
  • Weight loss
  • Overweight
  • Obesity
  • Cholesterol
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • of 25 or more (23 or more in persons of Asian origin).
  • Access to the internet.
  • English fluency.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Body weight greater than 182 kg.
  • Current diagnosis of eating disorder.
  • Intention to follow another weight loss method during the study period.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Low-fat, vegan diet

    All participants will be asked to follow a low-fat vegan diet. There are no other study arms or control group.

    Behavioral: Low-fat, vegan diet

Interventions

  • BehavioralLow-fat, vegan diet

    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.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  1. Changes in glycated hemoglobin.

    A1c will be measured using standard methods.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Oct 2028, 32 months after the start.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 32 months is above that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2025
First posted
Jul 31, 2025
StartActual
Jan 2, 2026
Primary completionEst.
Oct 1, 2028
CompletionEst.
Oct 30, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07095543
Lead sponsor
Physicians Committee for Responsible Medicine
Responsible party
Sponsor
First posted
Jul 31, 2025
Start date
Jan 2, 2026
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Vanita Rahman, MD, DipACLM
Contact
vrahman@pcrm.org
202-527-7500
Shannon Menhardt, MS, RD
Contact
smenhardt@pcrm.org
202-527-7500

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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