Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 70 participants
Start Date 2026-08-01
Est. Completion 2028-12-31
Phase NA

Sponsor

Florida State University

219 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.