DysbiosisNCT06916936
Effect of Peanut Butter on Gut and Metabolic Health
A study testing Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter and Cadbury Milk Chocolate Spread in people with Dysbiosis, run by Florida State University at 1 site in United States.
Trial summary
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter and Cadbury Milk Chocolate Spread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in elementary or middle school (grades 1-8)
- Aged 6-13 years old
- Ability to speak and read in English
Who cannot join
- 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 peanuts
- Any allergy to the isocaloric snack (chocolate or wheat)
- Regular consumption of nuts or peanuts 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%).
- Known to be pregnant (self-disclosed)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
FSU College of Education, Health and Human Services contact
United States1 site, 1 recruiting
- Recruiting
Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, 32306
Ravinder Nagpal, PhD, 850-644-1829, rnagpal@fsu.edu
Cole Patoine, MS, RDN, cjp23a@fsu.edu
About this study
Official title: Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:
Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children.
Read more
Secondary Objective(s)
- To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children.
- To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.
Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:
- The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
- The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.
- Conditions
- Dysbiosis
- Being tested
- Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter, Cadbury Milk Chocolate Spread
- Keywords
- microbiome, gut, nuts, peanut butter, metabolic health, dysbiosis, metagenomic, sleep quality, prebiotic, children
- Medical subject headings
- Dysbiosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creamy Richards 100% Peanuts! Creamy Natural Peanut ButterOther
Peanut Butter (PB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth peanut butter ("Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). The amount of peanut butter will be limited to 16g per two crackers, but additional crackers will be provided if the personalized portion exceeds this limit
Cadbury Milk Chocolate SpreadOther
Also called Control Snack, CTL, Isocaloric 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.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Butter Condition | Experimental | Peanut Butter (PB) Group: This condition involves a normal diet supplemented daily with a personalized portion of smooth peanut butter (Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter) sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). There is a limit of 16g of peanut butter per two crackers. The quantity of peanut butter 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. Receives: Other: Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter |
| Control Snack Condition | Active comparator | 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 Receives: Other: Cadbury Milk Chocolate Spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiome Diversity
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Measured: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
Change in Oral Microbiome Diversity
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
Measured: Baseline (day 0), Endpoint (week 8)
Change in Fecal Metabolome
The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.
Measured: Baseline (day 0) and Endpoint (week 8)
Change in Serum Metabolome
The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.
Measured: Baseline (day 0), and Endpoint (week 8).
Secondary outcomes (18)
Change in Gut Transit Time
Evaluate changes in gut transit time after peanut butter or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Measured: Baseline (day 0), and endpoint (week 8)
Change in Waist / Hip Circumference
Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during peanut butter consumption, compared to a control snack.
Measured: baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Habitual Dietary Intake
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR).
Measured: baseline (day 0), midpoint (week 4) and endpoint (week 8).
Change in Body Weight
the endpoint of body weight (kg) will be measured at each visit to assess changes in weight before and after 8 week consumption peanut butter or a control snack spread.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Urinary Melatonin
Changes in melatonin (urine metabolite 6-sulphatoxymelatonin) will be assessed before, during and after 8-week consumption of peanut butter or control snack spread.
Measured: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Change in Urinary Serotonin
Changes in urinary serotonin (urine metabolite 5-HIAA) will be assessed before, during and after 8-week consumption of peanut butter or control snack spread.
Measured: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Change in Body Fat Percentage
Evaluate changes in body composition, including fat mass, expressed as a percentage of total weight (%). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during peanut butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Lipid Profiles
Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL.
Measured: Baseline (day 0), endpoint (week 8)
Change in Biomarkers of Inflammation
Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL.
Measured: Baseline (day 0), Endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function
Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL.
Measured: Baseline (day 0), endpoint (week 8).
Change in Lean Mass
Evaluate changes in body composition, including lean mass (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during peanut butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Biomarkers of Appetite
Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL.
Measured: baseline (day 0), endpoint (week 8)
Change in Rested, Seated Blood Pressure
This outcome measure will measure changes in blood pressure taken at rest in the seated position at each visit, before during and after peanut butter or control snack consumption, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg).
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Fasting Blood Glucose
Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/DL).
Measured: Baseline (day 0), endpoint (week 8).
Dietary Adherence
Assess adherence to the intervention and control snack throughout the study, as determined by dietary adherence logs kept by the participants each week. Adherence is expressed as a daily percent (%) consumption of their assigned snack
Measured: Daily, baseline through endpoint (week 8)
Change in Total Body Water
Evaluate changes in body composition, including, total body water (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during peanut butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Intracellular Fluid
Evaluate changes in body composition, including intracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during peanut butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Extracellular Fluid
Evaluate changes in body composition, including extracellular fluid (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during peanut butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 Feb 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Peanut Institute
- Responsible party
- Principal investigator, Ravi Nagpal, Florida State University
- Investigators
- Ravinder Nagpal, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916936
- Sponsor's protocol ID
- STUDY00005388
- Other IDs
- FA0000072215
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
- ClinicalTrials.gov ID
- NCT06916936
- Acronym / sponsor ID
- STUDY00005388
- Conditions
- Dysbiosis
- Keywords
- microbiome, gut, nuts, peanut butter, metabolic health, dysbiosis, metagenomic, sleep quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- The Peanut Institute
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:
Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children.
Secondary Objective(s)
- To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children.
- To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.
Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:
- The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
- The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Butter Condition | Experimental | Other: Creamy Richards 100% Peanuts! Creamy Natural Peanut ButterPeanut Butter (PB) Group: This condition involves a normal diet supplemented daily with a personalized portion of smooth peanut butter (Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter) sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). There is a limit of 16g of peanut butter per two crackers. The quantity of peanut butter 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. |
| Control Snack Condition | Active comparator | Other: Cadbury Milk Chocolate SpreadControl (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 |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in elementary or middle school (grades 1-8)
- Aged 6-13 years old
- Ability to speak and read in English
Key exclusion criteria (8 listed)
- 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 the isocaloric snack (chocolate or wheat)
- Regular consumption of nuts or peanuts greater than 2 servings / week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creamy Richards 100% Peanuts! Creamy Natural Peanut ButterPeanut Butter (PB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth peanut butter ("Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). The amount of peanut butter will be limited to 16g per two crackers, but additional crackers will be provided if the personalized portion exceeds this limit | Other | Peanut Butter Condition |
| Cadbury Milk Chocolate SpreadAlso: Control Snack, CTL, Isocaloric SpreadControl (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. | Other | Control Snack Condition |
Primary outcome
Change in Gut Microbiome Diversity
Time frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Change in Oral Microbiome Diversity
Time frame: Baseline (day 0), Endpoint (week 8)
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
Change in Fecal Metabolome
Time frame: Baseline (day 0) and Endpoint (week 8)
The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.
Change in Serum Metabolome
Time frame: Baseline (day 0), and Endpoint (week 8).
The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.
18 secondary outcomes
Change in Gut Transit Time
Time frame: Baseline (day 0), and endpoint (week 8)
Change in Waist / Hip Circumference
Time frame: baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Habitual Dietary Intake
Time frame: baseline (day 0), midpoint (week 4) and endpoint (week 8).
Change in Body Weight
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Urinary Melatonin
Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Change in Urinary Serotonin
Time frame: Baseline (day 0) Midpoint (week 4), endpoint (week 8).
Change in Body Fat Percentage
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Lipid Profiles
Time frame: Baseline (day 0), endpoint (week 8)
Change in Biomarkers of Inflammation
Time frame: Baseline (day 0), Endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function
Time frame: Baseline (day 0), endpoint (week 8).
Change in Lean Mass
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Biomarkers of Appetite
Time frame: baseline (day 0), endpoint (week 8)
Change in Rested, Seated Blood Pressure
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Fasting Blood Glucose
Time frame: Baseline (day 0), endpoint (week 8).
Dietary Adherence
Time frame: Daily, baseline through endpoint (week 8)
Change in Total Body Water
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Intracellular Fluid
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Change in Extracellular Fluid
Time frame: Baseline (day 0), midpoint (week 4), endpoint (week 8).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- The corresponding official Gut Biome Lab website is linked hereLink provided by the sponsor.
- Individual participant dataSharing planned: No. Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FSU College of Education, Health and Human Services contact
Ravinder Nagpal, Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter and Cadbury Milk Chocolate Spread in people with Dysbiosis, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cole Patoine, MS, RDN (850-644-1828, cjp23a@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiome Diversity (time frame: Baseline (day 0) Midpoint (week 4), and endpoint (week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.