Almonds, Gut Microbiome, and Kids
Official title: Nutritional Impact of Almond Butter on Gut Microbiome and Cardiometabolic Health in School-Aged Children: A Novel and Timely Pilot Randomized Controlled Trial
Run by Florida State University · NCT07636850 · Data updated 2026-11-12
This 8-week study tests whether a daily almond butter snack can favorably impact gut bacteria and metabolic health in children aged 6–13 compared with a chocolate spread control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 13 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Status | Recruiting |
| Started | October 24, 2026 |
| Main results expected | October 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07636850 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–13 years in elementary or middle school, able to speak and read English, with no nut or almond allergies and no recent antibiotic or pre/pro/postbiotic use.
✕Probably not a fit
Children with nut allergies or those who already consume almonds frequently (>2 servings per week) may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This parallel-arm randomized trial will enroll 70 children aged 6–13 and randomize them to receive a daily almond butter snack or an isocaloric chocolate spread for 8 weeks, added to their usual diet. Primary outcomes focus on gut microbiome composition, microbial function, and markers of intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, inflammatory markers, appetite-related hormones, and sleep biomarkers, with feasibility and adherence tracked through logs and serum α-tocopherol. The study uses personalized portion sizes (16 g per day) and standard crackers to maintain consistency, and it will analyze metabolomics such as short-chain fatty acids and bile acids to understand functional gut changes.
Why it matters
Potential benefit: If successful, daily almond consumption could improve gut health and related metabolic indicators in school-aged children.
How similar studies have gone: Prior work in adults and pediatric populations suggests diet- and nut-based interventions can modulate the gut microbiome, though this exact almond butter approach in children is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 almonds * Any allergy to the isocaloric snack (chocolate or wheat) * Regular consumption of nuts or almonds 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%).
Where it's running
-
The Gut Biome Lab
Tallahassee, Florida, United States Recruiting
Study contacts
- Principal investigator: Ravinder Nagpal, PhD — Florida State University
- Study coordinator: Rayven Nairn, MS, RD
- Email: rsn25b@fsu.edu
- Phone: 850-644-1829
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pulse-focused nutrition for school-age children
This 6-week program tests whether a pulse-based diet (1.5 cups per week) improves gut health and metabolic markers in kids aged 6–13 who receive either pulses with education or pulses plus education and procurement support.
-
Effect of Periodontal Therapy on Gut Microbes and Inflammation in People with Inflammatory Bowel Disease
This study tests whether treating gum disease in people with inflammatory bowel disease can influence the gut microbiome and markers of systemic inflammation.
-
Cardiorespiratory and muscular fitness in children with obesity and autism
This study tests whether cardiorespiratory fitness and handgrip strength differ between children with obesity who have autism and those who do not, and how these fitness measures relate to body size, composition, and cardiometabolic health.
-
Impact of GLP-1 Receptor Agonist Therapy vs Structured Lifestyle on Weight and Health
This study tests whether starting a GLP-1 receptor agonist for weight loss works differently from a structured diet-and-exercise program in improving heart and metabolic health for adults with overweight or obesity.
-
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Researchers will look at how γδ T cells behave in severely ill patients, including those with sepsis, to see how their metabolism and function change.
-
How recreation influences choices that affect heart and metabolic health
This project will test whether increasing access to enjoyable recreational activities helps adults at risk for heart disease and type 2 diabetes make healthier daily choices.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.