DysbiosisNCT07648446
Pulse Education and Children
A study testing Education Only, Education + Pulse Provision and Cooking Class in people with Dysbiosis and Cardiometabolic Health Indicators, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status
- What is being tested?
- Education Only, Education + Pulse Provision and Cooking Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-13 years old
- Ability to speak English
Who cannot join
- 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
Show all 9Show fewer
- Those involved in another study concurrently
- Any allergies to pulses
- Intake of pre/pro/postbiotics in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
FSU College of Education, Health and Human Services contact
United States1 site, 1 recruiting
- Recruiting
The Gut Biome Lab
Tallahassee, Florida, 32306
Ravinder Nagpal, PhD, 850-644-1829, rnagpal@fsu.edu
Rayven Nairn, MS, RD
About this study
Official title: Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
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.
- Conditions
- Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status, Gut Motility
- Being tested
- Education Only, Education + Pulse Provision, Cooking Class
- Keywords
- gut, git microbiome, children, pediatric, pulses, beans, metabolomics, nutrition education, dietary adherence, fiber inake, plant-based, pulse consumption
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education OnlyOther
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.
Education + Pulse ProvisionOther
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 ClassOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education + Pulse Provision; Other: Cooking Class |
| 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. Receives: Other: Education Only; Other: Cooking Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 6
Change in Gut Barrier Function Markers
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
Measured: Baseline to Week 6
Secondary outcomes (7)
Sustainability of Pulse Intake
Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires.
Measured: Week 12 Follow-Up
Change in Blood Lipid Profile
Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
Measured: Baseline to Week 6
Change in Fasting Blood Glucose
Change in fasting blood glucose concentration measured from blood samples.
Measured: Baseline to Week 6
Change in Blood Metabolomic Profile
Change in circulating metabolomic signatures associated with pulse consumption and metabolic health.
Measured: 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.
Measured: Baseline to Week 6
Change in Inflammatory Biomarkers
Change in circulating and/or fecal biomarkers of inflammation.
Measured: 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.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ravi Nagpal, Florida State University
- Investigators
- Ravinder Nagpal, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648446
- Sponsor's protocol ID
- STUDY00006859
- Other IDs
- 58-3060-5-080
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
- ClinicalTrials.gov ID
- NCT07648446
- Acronym / sponsor ID
- STUDY00006859
- Conditions
- Dysbiosis, Cardiometabolic Health Indicators, Education on Feeding and Health Status, Gut Motility
- Keywords
- gut, git microbiome, children, pediatric, pulses, beans, metabolomics, nutrition education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education + Pulse Provision Condition | Experimental | Other: Education + Pulse Provision, Other: Cooking ClassParticipants 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 | Other: Education Only, Other: Cooking ClassParticipants 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-13 years old
- Ability to speak English
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education OnlyParticipants 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. | Other | Education Only Condition |
| Education + Pulse ProvisionParticipants 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. | Other | Education + Pulse Provision Condition |
| Cooking ClassThe 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 | Other | Education + Pulse Provision Condition, Education Only Condition |
Primary outcome
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.
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.
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.
Change in Gut Barrier Function Markers
Time frame: Baseline to Week 6
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
7 secondary outcomes
Sustainability of Pulse Intake
Time frame: Week 12 Follow-Up
Change in Blood Lipid Profile
Time frame: Baseline to Week 6
Change in Fasting Blood Glucose
Time frame: Baseline to Week 6
Change in Blood Metabolomic Profile
Time frame: Baseline to Week 6
Change in Gut Transit Time
Time frame: Baseline to Week 6
Change in Inflammatory Biomarkers
Time frame: Baseline to Week 6
Change in Gastrointestinal Tolerance Symptoms
Time frame: Baseline to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Gut Biome Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FSU College of Education, Health and Human Services contact
Ravinder Nagpal, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Only, Education + Pulse Provision and Cooking Class in people with Dysbiosis and Cardiometabolic Health Indicators, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rayven Nairn, MS, RD (850-644-1829, rsn25b@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Pulse Intake (time frame: Baseline to Week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.