- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: FSU College of Education, Health and Human Services
- Telefonszám: 850-644-1829
- E-mail: healthandhumansciences@fsu.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Rayven Nairn, MS, RD
- Telefonszám: 850-644-1829
- E-mail: rsn25b@fsu.edu
Tanulmányi helyek
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Florida
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Tallahassee, Florida, Egyesült Államok, 32306
- Toborzás
- The Gut Biome Lab
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Kapcsolatba lépni:
- Ravinder Nagpal, PhD
- Telefonszám: 850-644-1829
- E-mail: rnagpal@fsu.edu
-
Alkutató:
- Rayven Nairn, MS, RD
-
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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 |
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Aktív összehasonlító: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Adherence to Pulse Intake
Időkeret: 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
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Change in Gut Microbiome Composition and Diversity
Időkeret: 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
|
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Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations
Időkeret: Baseline to Week 6
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Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples. |
Baseline to Week 6
|
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Change in Gut Barrier Function Markers
Időkeret: Baseline to Week 6
|
Change in biomarkers of intestinal epithelial/barrier function measured in biological samples. |
Baseline to Week 6
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Sustainability of Pulse Intake
Időkeret: Week 12 Follow-Up
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Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires. |
Week 12 Follow-Up
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Change in Blood Lipid Profile
Időkeret: Baseline to Week 6
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Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. |
Baseline to Week 6
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Change in Fasting Blood Glucose
Időkeret: Baseline to Week 6
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Change in fasting blood glucose concentration measured from blood samples. |
Baseline to Week 6
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Change in Blood Metabolomic Profile
Időkeret: Baseline to Week 6
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Change in circulating metabolomic signatures associated with pulse consumption and metabolic health. |
Baseline to Week 6
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Change in Gut Transit Time
Időkeret: Baseline to Week 6
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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
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Change in Inflammatory Biomarkers
Időkeret: Baseline to Week 6
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Change in circulating and/or fecal biomarkers of inflammation. |
Baseline to Week 6
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Change in Gastrointestinal Tolerance Symptoms
Időkeret: Baseline to Week 6
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Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey. |
Baseline to Week 6
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Incidence of Gastrointestinal Symptoms
Időkeret: Baseline to Week 6
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Frequency and severity of gastrointestinal symptoms, including bloating, abdominal discomfort, gas, diarrhea, and constipation, reported during the intervention period. |
Baseline to Week 6
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Incidence of Adverse Events Related to Pulse Consumption
Időkeret: Baseline to Week 6
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Number and severity of adverse events judged to be related to study participation or pulse consumption. |
Baseline to Week 6
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Ravinder Nagpal, PhD, Florida State University
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- STUDY00006859
- 58-3060-5-080 (Egyéb támogatási/finanszírozási szám: USDA ARS)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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