Status:
RECRUITING
Effect of Peanut Butter on Gut and Metabolic Health
Lead Sponsor:
Florida State University
Collaborating Sponsors:
The Peanut Institute
Conditions:
Dysbiosis
Eligibility:
All Genders
6-13 years
Phase:
NA
Brief Summary
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main o...
Eligibility Criteria
Inclusion
- Enrolled in elementary or middle school (grades 1-8)
- Aged 6-13 years old
- Ability to speak and read in English
Exclusion
- 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)
Key Trial Info
Start Date :
February 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06916936
Start Date
February 9 2025
End Date
December 31 2025
Last Update
April 8 2025
Active Locations (1)
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1
Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, United States, 32306