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Plant-Based Diet for Obesity (SBPlant Trial)

N/A
Waitlist Available
Led By Miriam Jacome Sosa, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and immediately after the intervention at 6 months
Awards & highlights

SBPlant Trial Summary

This trial is studying a plant-based diet and culturally sensitive lifestyle intervention program to see if it can help Latino adults with obesity lose weight and improve their metabolic function.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on dietary intervention rather than medication, side effects may include digestive changes due to new eating habits but are generally expected to be minimal compared to drug treatments.

SBPlant Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediately after the intervention at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and immediately after the intervention at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body weight
Secondary outcome measures
Blood pressure
Fat mass and fat free mass
Insulin Clearance
+3 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

SBPlant Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral and Plant-based Dietary InterventionExperimental Treatment1 Intervention
In this arm, participants will receive the behavioral plant-based intervention from community health workers.
Group II: Standard CareActive Control1 Intervention
In this arm, participants will receive the standard care intervention from community health workers.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,018 Total Patients Enrolled
5 Trials studying Metabolic Diseases
1,196 Patients Enrolled for Metabolic Diseases
Sansum Diabetes Research InstituteOTHER
38 Previous Clinical Trials
2,238 Total Patients Enrolled
1 Trials studying Metabolic Diseases
12 Patients Enrolled for Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,146 Total Patients Enrolled
27 Trials studying Metabolic Diseases
6,195 Patients Enrolled for Metabolic Diseases

Media Library

Behavioral plant-based dietary intervention Clinical Trial Eligibility Overview. Trial Name: NCT05444595 — N/A
Metabolic Diseases Research Study Groups: Standard Care, Behavioral and Plant-based Dietary Intervention
Metabolic Diseases Clinical Trial 2023: Behavioral plant-based dietary intervention Highlights & Side Effects. Trial Name: NCT05444595 — N/A
Behavioral plant-based dietary intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444595 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left to join this experiment?

"Clinicaltrials.gov confirms that, as of 9/8/2022 when the study was last updated, this trial has stopped recruiting patients. Even so, there are still over a thousand medical trials actively enrolling participants at present."

Answered by AI

Am I able to partake in the current research study?

"This medical research is looking to enroll 40 Hispanic and/or Latino adults, aged 35 - 65 with a metabolic disorder. Additionally, the study requires that potential participants have a Body Mass Index between 30-42 kg/m² and an HbA1c of no more than 6.4%."

Answered by AI

Does the age of 85 preclude individuals from participating in this trial?

"Based on the requirements, individuals who are between 35 and 65 years old qualify for this medical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Behavioral Plant-Based Dietary Intervention in Latinos
2023. "Behavioral Plant-Based Dietary Intervention in Latinos". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05444595.
~19 spots leftby Feb 2025
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