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Pulse Education and Children

11. september 2026 oppdatert av: Ravi Nagpal, Florida State University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Rayven Nairn, MS, RD
  • Telefonnummer: 850-644-1829
  • E-post: rsn25b@fsu.edu

Studiesteder

  • Forente stater
    • Florida
      • Tallahassee, Florida, Forente stater, 32306
        • Rekruttering
        • The Gut Biome Lab
        • Ta kontakt med:
        • Underetterforsker:
          • Rayven Nairn, MS, RD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Education + 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.
Annen: Cooking 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
Aktiv komparator: 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.
Annen: Cooking 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

Annen: Education 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to Pulse Intake
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to Week 6
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
Baseline to Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sustainability of Pulse Intake
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to Week 6
Change in fasting blood glucose concentration measured from blood samples.
Baseline to Week 6
Change in Blood Metabolomic Profile
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to Week 6
Change in circulating and/or fecal biomarkers of inflammation.
Baseline to Week 6
Change in Gastrointestinal Tolerance Symptoms
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Gastrointestinal Symptoms
Tidsramme: 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
Tidsramme: Baseline to Week 6
Number and severity of adverse events judged to be related to study participation or pulse consumption.
Baseline to Week 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Florida State University

Etterforskere

  • Hovedetterforsker: Ravinder Nagpal, PhD, Florida State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. oktober 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

7. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00006859
  • 58-3060-5-080 (Annet stipend/finansieringsnummer: USDA ARS)

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NEI

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Nei

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Nei

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