Recruiting

Almond Butter

Sponsor:

Florida State University

Code:

NCT07636850

Conditions

Dysbiosis

Cardiometabolic Health Indicators

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

Interventions

Creamy Richards 100% Almonds! Creamy Natural Almond Butter

Cadbury Milk Chocolate Spread

Study Details

Brief 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.

Conditions

Dysbiosis

Cardiometabolic Health Indicators

Study ID

NCT07636850

Start date

Aug 1, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Accepted

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%).

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Almond Butter Condition

Participants in the ALB group will maintain their habitual diet supplemented with a once-daily snack of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with a maximum of 16g of almond butter per two crackers. The daily portion of almond butter will be individualized to provide 20% of each participant's estimated daily caloric needs, calculated using Dietary Guidelines for Americans (DGA) age- and sex-specific energy requirements.

active comparator: Control Snack Condition

Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender

Interventions

Creamy Richards 100% Almonds! Creamy Natural Almond Butter

Almond Butter (ALB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). The amount of almond butter will be limited to 16g per two crackers; additional crackers will be provided if the personalized portion exceeds this limit.

Cadbury Milk Chocolate Spread

Control (CTL) Group: Participants in this group will receive a daily snack consisting of an isocaloric amount of a nut-free, vegetable oil-based chocolate spread ("Cadbury Milk Chocolate") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). Similar to the peanut butter group, the chocolate spread will be limited to 16g per two crackers, with additional crackers provided if needed.

Primary outcome measure

  • Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples [ Time Frame: Baseline (day 0), midpoint (week 4) and endpoint (week 8) ]
  • Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs [ Time Frame: Baseline (day 0) and Endpoint (week 8) ]
  • Change in Fecal Metabolome [ Time Frame: Baseline (day 0) and endpoint (week 8) ]
  • Change in Serum Metabolome [ Time Frame: Baseline (day 0) and endpoint (week 8) ]

Central Contacts and Locations

Central contacts

Rayven Nairn, MS, RD

850-644-1829rsn25b@fsu.edu

FSU College of Education, Health and Human Services

850-644-1829healthandhumansciences@fsu.edu

Locations

The Gut Biome Lab

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Ravinder Nagpal, PhD

850-644-1829rnagpal@fsu.edu

More Information

Sponsor

Florida State University

Last update posted

Jun 9, 2026

Last verified

May, 2026

Keywords

  • gut
  • gut microbiome
  • children
  • pediatric
  • sleep quality
  • almonds
  • nuts
  • almond butter
  • metabolomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-06-09.