Cardiometabolic Health Indicators, Dysbiosis, Education on Feeding and Health Status, Gut Motility
Conditions
Keywords
gut, git microbiome, children, pediatric, pulses, beans, metabolomics, nutrition education, dietary adherence, fiber inake, plant-based, pulse consumption
Brief summary
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.
Interventions
OTHEREducation Only
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.
OTHEREducation + Pulse Provision
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.
OTHERCooking Class
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
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Pulse Intake | 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. |
| Change in Gut Microbiome Composition and Diversity | Baseline to Week 6 | Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples. |
| Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations | Baseline to Week 6 | Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples. |
| Change in Gut Barrier Function Markers | Baseline to Week 6 | Change in biomarkers of intestinal epithelial/barrier function measured in biological samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustainability of Pulse Intake | Week 12 Follow-Up | Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires. |
| Change in Blood Lipid Profile | Baseline to Week 6 | Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. |
| Change in Fasting Blood Glucose | Baseline to Week 6 | Change in fasting blood glucose concentration measured from blood samples. |
| Change in Blood Metabolomic Profile | Baseline to Week 6 | Change in circulating metabolomic signatures associated with pulse consumption and metabolic health. |
| Change in Gut Transit Time | 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. |
| Change in Inflammatory Biomarkers | Baseline to Week 6 | Change in circulating and/or fecal biomarkers of inflammation. |
| Change in Gastrointestinal Tolerance Symptoms | Baseline to Week 6 | Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey. |
Countries
United States
Contacts
CONTACTRayven Nairn, MS, RD
CONTACTFSU College of Education, Health and Human Services
PRINCIPAL_INVESTIGATORRavinder Nagpal, PhD
Florida State University
Outcome results
None listed