- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07648446
Pulse Education and Children
Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: FSU College of Education, Health and Human Services
- Phone Number: 850-644-1829
- Email: healthandhumansciences@fsu.edu
Study Contact Backup
- Name: Rayven Nairn, MS, RD
- Phone Number: 850-644-1829
- Email: rsn25b@fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Recruiting
- The Gut Biome Lab
-
Contact:
- Ravinder Nagpal, PhD
- Phone Number: 850-644-1829
- Email: rnagpal@fsu.edu
-
Sub-Investigator:
- Rayven Nairn, MS, RD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 6-13 years old
- Ability to speak English
Exclusion Criteria:
- Frequent pulse consumers (>0.5 cup/week for females and >1 cup / week for males)
- Antibiotic use in the past 3 months
- Diagnosed metabolic/gut diseases (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C > 9%).
- Current use of medications or nutrition supplements
- Individuals following a specific dietary patten
- Individuals who gained or lost >5% body weight within the past 6 months
- Those involved in another study concurrently
- Any allergies to pulses
- Intake of pre/pro/postbiotics in the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education + Pulse Provision Condition
Participants will a six-week pulse education program similar to the education-only group.
However, this group will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions.
In addition to education, families will receive free weekly supply of pulses, pre-measured and packaged according to a stepwise intake plan (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6).
The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research.
Families will be asked to prepare three pulse-based meals per week and complete adherence tracking.
Pulse provisions are scaled to household size to ensure all members meet intake goals.
|
Participants will receive the same six-week pulse education program as the EO group.
To further improve success, EP will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions.
In addition to education, EP families will receive free weekly supply of pulses, pre-measured and packaged according to the same stepwise intake plan.
The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research.
Families prepare three pulse-based meals per week and complete the same adherence tracking as the EO group.
Pulse provisions are scaled to household size to ensure all members meet intake goals.
The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week. On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed. Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi |
|
Active Comparator: Education Only Condition
Participants will receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods.
Families will be asked to prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently.
Adherence is tracked through weekly food logs, checklists, and surveys on child acceptance, meal satisfaction, and preparation feasibility.
|
The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week. On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed. Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi
Participants receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods.
Families prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently.
One of four pulses (lentils, chickpeas, black eye peas, black beans) will be assigned each week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Pulse Intake
Time Frame: Baseline to Week 6
|
Proportion of participants achieving the prescribed pulse intake of ≥1.5 cups per week, assessed using dietary records and pulse meal logs.
|
Baseline to Week 6
|
|
Change in Gut Microbiome Composition and Diversity
Time Frame: Baseline to Week 6
|
Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples.
|
Baseline to Week 6
|
|
Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations
Time Frame: Baseline to Week 6
|
Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples.
|
Baseline to Week 6
|
|
Change in Gut Barrier Function Markers
Time Frame: Baseline to Week 6
|
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
|
Baseline to Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sustainability of Pulse Intake
Time Frame: Week 12 Follow-Up
|
Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires.
|
Week 12 Follow-Up
|
|
Change in Blood Lipid Profile
Time Frame: Baseline to Week 6
|
Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
|
Baseline to Week 6
|
|
Change in Fasting Blood Glucose
Time Frame: Baseline to Week 6
|
Change in fasting blood glucose concentration measured from blood samples.
|
Baseline to Week 6
|
|
Change in Blood Metabolomic Profile
Time Frame: Baseline to Week 6
|
Change in circulating metabolomic signatures associated with pulse consumption and metabolic health.
|
Baseline to Week 6
|
|
Change in Gut Transit Time
Time Frame: Baseline to Week 6
|
Evaluate changes in gut transit time after pulse consumption for 6 weeks from baseline to final analysis, using a blue-dye capsule.
|
Baseline to Week 6
|
|
Change in Inflammatory Biomarkers
Time Frame: Baseline to Week 6
|
Change in circulating and/or fecal biomarkers of inflammation.
|
Baseline to Week 6
|
|
Change in Gastrointestinal Tolerance Symptoms
Time Frame: Baseline to Week 6
|
Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey.
|
Baseline to Week 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Gastrointestinal Symptoms
Time Frame: Baseline to Week 6
|
Frequency and severity of gastrointestinal symptoms, including bloating, abdominal discomfort, gas, diarrhea, and constipation, reported during the intervention period.
|
Baseline to Week 6
|
|
Incidence of Adverse Events Related to Pulse Consumption
Time Frame: Baseline to Week 6
|
Number and severity of adverse events judged to be related to study participation or pulse consumption.
|
Baseline to Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ravinder Nagpal, PhD, Florida State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006859
- 58-3060-5-080 (Other Grant/Funding Number: USDA ARS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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