DysbiosisNCT07636850
Almonds, Gut Microbiome and Kids
A study testing Creamy Richards 100% Almonds! Creamy Natural Almond Butter and Cadbury Milk Chocolate Spread in people with Dysbiosis and Cardiometabolic Health Indicators, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis, Cardiometabolic Health Indicators
- What is being tested?
- Creamy Richards 100% Almonds! Creamy Natural Almond Butter and Cadbury Milk Chocolate Spread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2028
- 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 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%).
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
The Gut Biome Lab
Tallahassee, Florida, 32306
Ravinder Nagpal, PhD, 850-644-1829, rnagpal@fsu.edu
Cole Patoine, MS, RD
About this study
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
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
- Being tested
- Creamy Richards 100% Almonds! Creamy Natural Almond Butter, Cadbury Milk Chocolate Spread
- Keywords
- gut, gut microbiome, children, pediatric, sleep quality, almonds, nuts, almond butter, metabolomics
- 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% Almonds! Creamy Natural Almond ButterOther
Also called ALB, 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 SpreadOther
Also called CTL, Isocaloric spread, Control
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 |
|---|---|---|
| Almond Butter Condition | Experimental | 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. Receives: Other: Creamy Richards 100% Almonds! Creamy Natural Almond 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 Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples
Freshly voided fecal samples will be collected and DNA extracted using the PowerFecal Pro DNA kit. The V3-V4 hypervariable region of the bacterial 16S ribosomal RNA gene will be PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess microbial diversity (alpha and beta diversity) and taxonomic composition.
Measured: 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
Oral biofilm swabs (omniswab - tongue, palate, cheek/lip lining, gums) and unstimulated saliva will be collected in 5ml tubes. DNA will be extracted and the V3-V4 region of the bacterial 16S ribosomal RNA gene PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess oral microbial diversity (alpha and beta diversity) and taxonomic composition.
Measured: Baseline (day 0) and 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 almond 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 almond butter intake affects metabolic processes and gut health.
Measured: Baseline (day 0) and endpoint (week 8)
Secondary outcomes (17)
Change in Gut Transit Time
Evaluate changes in gut transit time after almond 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 almond butter consumption, compared to a control snack.
Measured: Baseline (week 0), midpoint (week 4), and 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 of almond 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 almond butter or control snack spread.
Measured: Baseline (day 0), midpoint (week 4), and 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 almond butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), and 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) and 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) and 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) and 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 almond butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), and 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) and 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 almond 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), and 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) and 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 (day 0) 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 almond butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), and 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 almond butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), and 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 almond butter or control snack consumption.
Measured: Baseline (day 0), midpoint (week 4), and 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 posted9 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Ravi Nagpal, Florida State University
- Investigators
- Ravinder Nagpal, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636850
- Sponsor's protocol ID
- STUDY00007355
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07636850
- Acronym / sponsor ID
- STUDY00007355
- Conditions
- Dysbiosis, Cardiometabolic Health Indicators
- Keywords
- gut, gut microbiome, children, pediatric, sleep quality, almonds, nuts, almond butter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jun 2026 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Butter Condition | Experimental | Other: Creamy Richards 100% Almonds! Creamy Natural Almond ButterParticipants 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. |
| 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 (7 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 almonds 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% Almonds! Creamy Natural Almond ButterAlso: ALB, Almond ButterAlmond 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. | Other | Almond Butter Condition |
| Cadbury Milk Chocolate SpreadAlso: CTL, Isocaloric spread, ControlControl (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 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)
Freshly voided fecal samples will be collected and DNA extracted using the PowerFecal Pro DNA kit. The V3-V4 hypervariable region of the bacterial 16S ribosomal RNA gene will be PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess microbial diversity (alpha and beta diversity) and taxonomic composition.
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)
Oral biofilm swabs (omniswab - tongue, palate, cheek/lip lining, gums) and unstimulated saliva will be collected in 5ml tubes. DNA will be extracted and the V3-V4 region of the bacterial 16S ribosomal RNA gene PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess oral microbial diversity (alpha and beta diversity) and taxonomic composition.
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 almond 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 almond butter intake affects metabolic processes and gut health.
17 secondary outcomes
Change in Gut Transit Time
Time frame: Baseline (day 0) and endpoint (week 8)
Change in Waist/Hip Circumference
Time frame: Baseline (week 0), midpoint (week 4), and 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), and endpoint (week 8)
Change in Body Fat Percentage
Time frame: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Lipid Profiles
Time frame: Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Inflammation
Time frame: Baseline (day 0) and endpoint (week 8)
Change in Biomarkers of Intestinal Barrier Function
Time frame: Baseline (day 0) and endpoint (week 8)
Change in Lean Mass
Time frame: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Biomarkers of Appetite
Time frame: Baseline (day 0) and endpoint (week 8)
Change in Rested, Seated Blood Pressure
Time frame: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Fasting Blood glucose
Time frame: Baseline (day 0) and endpoint (week 8)
Dietary Adherence
Time frame: Daily, baseline (day 0) through endpoint (week 8)
Change in Total Body Water
Time frame: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Intracellular Fluid
Time frame: Baseline (day 0), midpoint (week 4), and endpoint (week 8)
Change in Extracellular Fluid
Time frame: Baseline (day 0), midpoint (week 4), and 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 15 Sep 2026.
- Lab WebsiteLink 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, PhD 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% Almonds! Creamy Natural Almond Butter and Cadbury Milk Chocolate Spread in people with Dysbiosis and Cardiometabolic Health Indicators, 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 7 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 15 Sep 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 Rayven Nairn, MS, RD (850-644-1829, rsn25b@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 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)). 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 15 Sep 2026.