Impact of peanut butter on gut and metabolic health in children
Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
This study tests if eating smooth peanut butter every day can improve gut and metabolic health in children aged 6 to 13.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT06916936 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of daily smooth peanut butter consumption on gut and metabolic health in children aged 6 to 13. It is a parallel arm, randomized trial that aims to assess the prebiotic effects of peanut butter over an eight-week period, focusing on gut health metrics such as microbiome composition and gut barrier function. Additionally, the study will evaluate metabolic and inflammatory health markers, as well as sleep quality, to understand the broader implications of incorporating peanut butter into children's diets.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-13 who are enrolled in elementary or middle school and can read and speak English.
Not a fit: Patients with food allergies to peanuts or nuts, gastrointestinal diseases, or those who have recently taken antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve gut and metabolic health in children.
How similar studies have performed: While there is ongoing research into dietary impacts on gut health, this specific approach using peanut butter is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in elementary or middle school (grades 1-8) * Aged 6-13 years old * Ability to speak and read in English Exclusion Criteria: * Intake of antibiotics in the last 3 months * Intake of pre/pro/postbiotics in the last 3 months * Food allergy to study foods * Any allergy to nuts or peanuts * Any allergy to the isocaloric snack (chocolate or wheat) * Regular consumption of nuts or peanuts greater than 2 servings / week * Gastrointestinal disease (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%). * Known to be pregnant (self-disclosed)
Where this trial is running
Tallahassee, Florida
- Florida State Univresity - The Gut Biome Lab — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ravinder Nagpal, Ph.D. — Florida State University
- Study coordinator: Cole Patoine, MS, RDN
- Email: cjp23a@fsu.edu
- Phone: 850-644-1828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.