Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 58-3060-5-080 | Other Grant/Funding Number | USDA ARS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education + Pulse Provision Condition | Experimental | 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. |
|
| Education Only Condition | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education Only | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Pulse Intake | 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 | 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 | 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 | Change in biomarkers of intestinal epithelial/barrier function measured in biological samples. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability of Pulse Intake | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Gastrointestinal Symptoms | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rayven Nairn, MS, RD | Contact | 850-644-1829 | rsn25b@fsu.edu | |
| FSU College of Education, Health and Human Services | Contact | 850-644-1829 | healthandhumansciences@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ravinder Nagpal, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Gut Biome Lab | Recruiting | Tallahassee | Florida | 32306 | United States |
Not provided
| Label | URL |
|---|---|
| Gut Biome Lab Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Education + Pulse Provision | Other | 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. |
|
| Cooking Class | Other | 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 |
|
Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
| Baseline to Week 6 |
| Change in Fasting Blood Glucose | Change in fasting blood glucose concentration measured from blood samples. | Baseline to Week 6 |
| Change in Blood Metabolomic Profile | Change in circulating metabolomic signatures associated with pulse consumption and metabolic health. | Baseline to Week 6 |
| Change in Gut Transit Time | 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 | Change in circulating and/or fecal biomarkers of inflammation. | Baseline to Week 6 |
| Change in Gastrointestinal Tolerance Symptoms | Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey. | Baseline to Week 6 |
Number and severity of adverse events judged to be related to study participation or pulse consumption. |
| Baseline to Week 6 |