Plant-Based Diet for Obesity

(SB Pilot Trial)

Overseen By Miriam Jacome Sosa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Outcome-affecting medications

Disqualifiers: Diabetes, Cardiovascular disease, Organ dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a tasty, plant-based diet to help Latino adults with obesity lose weight and improve health. The study will also create a lifestyle program, guided by community health workers, to help participants integrate this diet into their daily lives. Participants will be divided into two groups: one will follow the behavioral plant-based dietary intervention, while the other will receive standard care. Ideal candidates are Latino adults who are not diabetic and have a Body Mass Index (BMI) between 30 and 42, a measure of body fat based on height and weight. As an unphased trial, this study offers a unique opportunity to contribute to innovative dietary research and potentially enhance personal health.

Do I need 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 excludes those using medications that could affect the study's outcome. It's best to discuss your specific medications with the trial team.

What prior data suggests that this dietary intervention is safe for weight loss in the Latino population?

Research has shown that plant-based diets can be safe and beneficial for people with obesity. Studies have found that these diets aid in weight loss and improve heart health. Those who primarily consume plants tend to have lower rates of overweight and obesity compared to individuals who consume more meat and processed foods.

Early findings suggest that most people tolerate plant-based diets well. Research with Latino communities has focused on adapting these diets to cultural preferences, which helps individuals maintain them and experience health benefits. Many report positive changes, such as improved metabolism and reduced risk factors for diabetes, without serious side effects.

Overall, evidence suggests that plant-based diets are a safe choice for improving health, particularly for those dealing with obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional obesity treatments that often rely on medication or surgical intervention, the plant-based dietary intervention offers a natural and behavioral approach to weight management. Researchers are excited because this method focuses on a whole-food, plant-based diet, which is rich in nutrients and fiber, potentially leading to improved metabolic health and sustainable weight loss without the need for drugs. Moreover, this approach promotes long-term lifestyle changes by involving community health workers to support participants, making it a holistic alternative to conventional treatments.

What evidence suggests that this plant-based dietary intervention is effective for obesity?

Research has shown that plant-based diets can aid in weight loss. Individuals who consume more plant-based foods often maintain lower body weight and face a reduced risk of obesity compared to those who consume more meat and processed foods. A review of various studies found that plant-based diets, adapted to fit different cultures, increased fruit and vegetable intake, which also helped reduce obesity. One analysis found that vegan diets resulted in more weight loss than diets including dairy and eggs. In this trial, participants in the experimental arm will receive a behavioral plant-based dietary intervention, aiming to leverage these benefits to manage weight and improve health. ^{5 6 7 8 9}

Who Is on the Research Team?

Miriam Jacome Sosa, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for Latino adults with obesity (BMI of 30-42 kg/m²) who do not have diabetes, severe health conditions, or recent significant weight changes. Participants should not be pregnant, breastfeeding, or using medications that affect the study's outcomes.

Inclusion Criteria

Self-reported Hispanic and/or Latino heritage

HbA1c ≤ 6.4%

Body Mass Index (BMI) 30-42 kg/m²

Exclusion Criteria

I have not had severe heart problems in the last 6 months.

Unstable weight (≥4% during the last 2 months prior to study enrollment)

I have a major organ that is not working properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week behavioral plant-based dietary intervention delivered by community health workers

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral plant-based dietary intervention

Trial Overview The study is testing a culturally sensitive plant-based diet against standard care in Latinos to see if it helps lose weight and improve metabolic health. It involves a 16-week program delivered by community health workers.

How Is the Trial Designed?

Group I: Behavioral and Plant-based Dietary Intervention Experimental Treatment 1 Intervention

In this arm, participants will receive the behavioral plant-based intervention from community health workers.

Group II: Standard Care Active Control 1 Intervention

In this arm, participants will receive the standard care intervention from community health workers.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Sansum Diabetes Research Institute

Collaborator

Trials

39

Recruited

2,300+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5466943/

A plant-based diet for overweight and obesity prevention ... In summary, individuals consuming PBDs tend to have lower BMI than those consuming non-PBDs. The adoption of PBDs also appears effective for weight loss.

2. lifestylemedicine.org lifestylemedicine.org/benefits-plant-based-nutrition-obesity/

The benefits of plant-based nutrition: Obesity & weight ... Individuals consuming more plant-based diets have lower rates of overweight and obesity than those whose diets include or emphasize meat and refined foods.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000634

Review article Culturally-tailored plant-based interventions ... Our review showed that culturally-tailored plant-based nutrition interventions improved the consumption of vegetables and fruits in six studies, lowered obesity ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185447/

Effectiveness of a Remotely Delivered Whole Food Plant ... This pilot study evaluated a 5-week, remotely delivered WFPB intervention with online community support among 18 women with overweight or obesity.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.952553/full

Plant-based diet for obesity treatment A meta-analysis of 1,151 patients found that vegan diets resulted in greater weight loss than lacto-ovo-vegetarian diets (50). It is critical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930444/

Culturally-tailored plant-based interventions to improve health ... The purpose of this integrative review was to explore culturally-tailored plant-based dietary interventions to improve health outcomes in pediatric populations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9493195/

Plant-based diet for obesity treatment - PMC PBD is a beneficial approach to improving health, particularly in obese patients. Benefits include weight loss, improved cardiovascular health, lower blood ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05444595

Behavioral Plant-Based Dietary Intervention in Latinos A behavioral and plant-based dietary intervention to improve metabolic health and diabetes risk factors in an underserved Latino population conditions.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2802814

Association of Plant-based Diet Adherence With Risk ... Greater adherence to a healthful plant-based diet was associated with a lower risk of mortality, cancer, and particularly cardiovascular disease.