60 Participants NeededMy employer runs this trial

Pulse-Based Nutrition for Digestive Issues

RN
FC
Overseen ByFSU College of Education, Health and Human Services
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This parallel-arm, randomized controlled trial will evaluate the effectiveness of a 6-week pulse-focused nutrition intervention in school-aged children (6-13 years). The study aims to assess adherence to a pulse-based diet providing 1.5 cups of pulses per week and to examine the effects of whole-cooked pulse consumption on gut health, including gut microbiome composition, metabolomic profiles, and gut barrier function. Secondary objectives include evaluating the impact of pulse consumption on markers of metabolic health and inflammation. Forty participants will be randomized to either a pulse-focused nutrition education program with weekly provision of pre-measured pulses (black beans, lentils, and chickpeas) or a pulse-focused nutrition education program in which participants independently procure their own pulses. Participants will follow the assigned intervention for 6 weeks.

Who Is on the Research Team?

RN

Ravinder Nagpal, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for children ages 6-13 who are able to follow a pulse-based diet and participate in nutrition education. Children with certain health conditions or dietary restrictions may not be eligible.

Inclusion Criteria

Ability to speak English
I am between 6 and 13 years old.

Exclusion Criteria

Frequent pulse consumers (>0.5 cup/week for females and >1 cup/week for males)
I have a neurological disorder like multiple sclerosis, meningitis, or a recent stroke.
I am currently taking medications or nutrition supplements.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week pulse-focused nutrition intervention, including education and pulse provision or independent procurement

6 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for sustainability of pulse intake and health markers after the intervention

6 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two groups: one receives nutrition education plus weekly pre-measured pulses (like beans, lentils, chickpeas), while the other gets only education and buys their own pulses. Both interventions last 6 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Education + Pulse Provision ConditionExperimental Treatment2 Interventions
Group II: Education Only ConditionActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+