Almonds, Gut Microbiome and Kids (NCT07636850)
Nutritional Impact of Almond Butter on Gut Microbiome and Cardiometabolic Health in School-Aged Children: A Novel and Timely Pilot Randomized Controlled Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum ฮฑ-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage. This pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.
Who can join: Review the eligibility criteria below.
Location: The Gut Biome Lab โ Tallahassee, Florida
Age range: 6 Years to 13 Years
๐งช Interventions in This Study
- Creamy Richards 100% Almonds! Creamy Natural Almond Butter (OTHER)
- Cadbury Milk Chocolate Spread (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- The Gut Biome Lab โ Tallahassee, Florida
๐ Contact the Study Coordinator
Phone: (850) 644-1829
Email: rsn25b@fsu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Dysbiosis
- REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs โ Philadelphia, Pennsylvania
- My Baby Biome: Infant Stool Samples for Microbiome Health (MBB) โ San Diego, California
- Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health โ Tallahassee, Florida
- Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery โ Philadelphia, Pennsylvania
- Pulse Education and Children โ Tallahassee, Florida
Explore by condition: All Dysbiosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.