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Pulses for Obesity (PS Trial)

N/A
Waitlist Available
Led By Indika Edirisinghe, Ph.D
Research Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology
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 to 12 weeks

Summary

This trial will study the effects of eating pulses (legumes) on obesity, inflammation, and gut microbiota in humans.

Who is the study for?
This trial is for men and women over 18 with a BMI ≥ 25, fasting blood glucose between 100-125 mg/dL, non-smokers or those who quit over two years ago. Participants should be in good health without major diseases or taking medications that affect the study outcomes. They must not drink alcohol or engage in vigorous exercise before visits.
What is being tested?
The trial examines how eating pulses (black beans and chickpeas) versus a control diet for 12 weeks affects systemic inflammation, insulin sensitivity, gut microbiome composition, metabolite pools, and cognitive function in overweight/obese individuals with insulin resistance.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort due to dietary changes when consuming pulses compared to their regular diet. However, specific side effects will depend on individual reactions to increased fiber intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in plasma systemic and gut inflammatory markers
Describe functional metagenomics alterations in gut microbiome
Determination of GLP-2 in plasma
+3 more
Secondary study objectives
Characterize bile acid metabolite pool
Characterize metabolite profiles
Other study objectives
Cognitive assessment: basic attention, and working memory.
Cognitive assessment: learning
Cognitive assessment: verbal phonemic (letter) and semantic (category) fluency

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Black beanActive Control1 Intervention
A cup of black bean 7 days/week over a 12-week period
Group II: ChickpeaActive Control1 Intervention
A cup of chickpea 7 days/week over a 12-week period
Group III: ControlPlacebo Group1 Intervention
A cup of white rice 7 days/week over a 12-week period

Find a Location

Who is running the clinical trial?

USDA Beltsville Human Nutrition Research CenterFED
54 Previous Clinical Trials
5,178 Total Patients Enrolled
5 Trials studying Inflammation
643 Patients Enrolled for Inflammation
Clinical Nutrition Research Center, Illinois Institute of TechnologyLead Sponsor
54 Previous Clinical Trials
2,897 Total Patients Enrolled
6 Trials studying Inflammation
247 Patients Enrolled for Inflammation
Indika Edirisinghe, Ph.DPrincipal InvestigatorIllinois Insititute of Technology
3 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Inflammation
13 Patients Enrolled for Inflammation

Media Library

Inflammation Research Study Groups: Black bean, Chickpea, Control
Inflammation Clinical Trial 2023: Black bean Highlights & Side Effects. Trial Name: NCT04267705 — N/A
Black bean (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267705 — N/A
~18 spots leftby Dec 2025
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