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NCT07636850 · ClinicalTrials.gov registry record · NA
Almonds, Gut Microbiome and Kids
A NA study, sponsored by Florida State University.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT07636850 is a NA study that is actively recruiting participants, run by Florida State University. The registered enrollment target is 70 participants.
The verdict
NCT07636850, a NA study, is actively recruiting participants, sponsored by Florida State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
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 α-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.
Interventions
- OTHER Cadbury Milk Chocolate Spread
- OTHER Creamy Richards 100% Almonds! Creamy Natural Almond Butter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07636850
The ClinicalTrials.gov registry entry for NCT07636850 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cadbury Milk Chocolate Spread is the first listed.
NCT07636850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07636850 about?
NCT07636850 is a clinical study titled "Almonds, Gut Microbiome and Kids". 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 ...
What is the current status of trial NCT07636850?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2026-08-01. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT07636850?
The interventions under investigation include: Cadbury Milk Chocolate Spread (OTHER), Creamy Richards 100% Almonds! Creamy Natural Almond Butter (OTHER).
Who is sponsoring clinical trial NCT07636850?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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