Plant-Based Diet for Weight Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

Disqualifiers: Recreational drugs, Pregnancy, Unstable illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that you can maintain your current medication regimen.

Is a plant-based diet safe for weight loss?

Research suggests that plant-based diets are generally safe and can lead to weight loss, lower cholesterol, and reduced cardiovascular risk. However, the quality of plant-based foods consumed is important for health benefits. ^{1 2 3 4 5}

How does the Plant-Based Weight-Loss Program differ from other weight loss treatments?

The Plant-Based Weight-Loss Program is unique because it focuses on a whole food, plant-based diet that traps some calories within indigestible cell walls, reducing their absorption and promoting weight loss without calorie restriction or mandatory exercise. This approach not only aids in weight loss but also has the potential to reverse heart disease and improve other chronic conditions like type 2 diabetes and hypertension. ^{2 6 7 8 9}

What data supports the effectiveness of the Plant-Based Weight-Loss Program treatment for weight loss?

Research shows that plant-based diets can help with weight loss and prevent obesity. A 16-week study found that a plant-based diet improved body composition and reduced insulin resistance (a condition where the body doesn't respond well to insulin). Another review highlighted that plant-based diets are effective for weight loss and offer better diet quality compared to other diets. ^{7 10 11 12 13}

Who Is on the Research Team?

VANITA RAHMAN, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who want to lose weight and may have conditions like diabetes, high blood pressure, or lipid disorders. Participants should not be using recreational drugs, pregnant, or planning pregnancy during the study. They must speak English fluently and commit to the study's requirements without changing their current medication.

Exclusion Criteria

You have used drugs for fun in the last 6 months.

Pregnancy or intention to become pregnant during the study period, as verified by self-report

I do not have any unstable medical or mental health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-week plant-based, weight-loss program with weekly education and support sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plant-Based Weight-Loss Program

Trial Overview The trial is testing a low-fat plant-based diet in an office setting for 12 weeks to see if it's practical and effective. It will measure changes in body weight, blood pressure, cholesterol levels (plasma lipids), blood sugar control (glycated hemoglobin), and body composition.

How Is the Trial Designed?

Group I: Low-fat plant-based diet Experimental Treatment 1 Intervention

For 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.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+

Published Research Related to This Trial

A new Plant-Based Diet (PBD) scoring system was developed to evaluate adherence to PBDs in Japanese patients with inflammatory bowel disease (IBD), showing significant differences in scores based on dietary types.

Patients with Crohn disease who maintained a high PBD score (25 or greater) were more likely to achieve long-term remission and have normal C-reactive protein levels, indicating a potential link between PBD adherence and improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Application of a Plant-Based Diet Scoring System for Japanese Patients with Inflammatory Bowel Disease. Chiba, M., Nakane, K., Takayama, Y., et al.[2019]

A community-based dietary program using a whole food plant-based (WFPB) diet resulted in a significant reduction in BMI after 6 months, with an average decrease of 4.4 kg/m² compared to only 0.4 kg/m² in the control group.

Participants following the WFPB diet also experienced a meaningful reduction in cholesterol levels, achieving a significant decrease at 12 months, with no serious harms reported, indicating the diet's safety and potential efficacy for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Wright, N., Wilson, L., Smith, M., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Group approach to weight control: behavior modification, nutrition, and health education. [2008]

3. China pubmed.ncbi.nlm.nih.gov

A plant-based diet for overweight and obesity prevention and treatment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A systematic review of targeted outcomes associated with a medically supervised commercial weight-loss program. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The healthful plant-based diet index as a tool for obesity prevention-The healthy lifestyle community program cohort 3 study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Development and Application of a Plant-Based Diet Scoring System for Japanese Patients with Inflammatory Bowel Disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Healthy plant-based diets and their short-term effects on weight loss, nutrient intake and serum cholesterol levels. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A short-term religious "fast" from animal products has a minimal impact on cardiometabolic health biomarkers irrespective of concurrent shifts in distinct plant-based food groups. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors in vegans; A meta-analysis of observational studies. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

A Whole Food Plant-Based Diet Is Effective for Weight Loss: The Evidence. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Whole-Food Plant-Based Lifestyle Program and Decreased Obesity. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets. [2017]