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Search / Trial NCT06916936

Effect of Peanut Butter on Gut and Metabolic Health

Launched by FLORIDA STATE UNIVERSITY · Apr 1, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Microbiome Gut Nuts Peanut Butter Metabolic Health Dysbiosis Metagenomic Sleep Quality Prebiotic Children

ClinConnect Summary

This clinical trial is studying how eating smooth peanut butter every day for eight weeks can affect the gut and overall health of children aged 6 to 13. Researchers want to see if peanut butter can help improve gut health, which is important for digestion and overall wellness. They are comparing two groups of children: one group will eat peanut butter with their regular meals, while the other group will have a similar amount of a nut-free chocolate spread instead. The study will also look at changes in inflammation, sleep quality, and how easy it is to add peanut butter to children’s diets.

To participate, children need to be between 6 and 13 years old and enrolled in elementary or middle school. They should be able to read and speak English. However, some children may not be eligible if they have certain allergies, have taken antibiotics or specific supplements recently, or have gastrointestinal or other health issues. Participants can expect to be part of a study that could help us understand more about the benefits of peanut butter in children's diets, and they will be monitored throughout the eight weeks to track any health changes.

Gender

ALL

Eligibility 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)

About Florida State University

Florida State University (FSU) is a prestigious public research institution located in Tallahassee, Florida, known for its commitment to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, FSU leverages its extensive academic resources and expertise to conduct rigorous research aimed at improving patient outcomes and contributing to the medical community. The university fosters a collaborative environment that brings together multidisciplinary teams to design, implement, and analyze clinical studies, ensuring adherence to the highest ethical and scientific standards. Through its clinical trials, FSU aims to address critical health challenges and translate research findings into practical applications that benefit society.

Locations

Tallahassee, Florida, United States

Patients applied

0 patients applied

Trial Officials

Ravinder Nagpal, Ph.D.

Principal Investigator

Florida State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported