Microbiome AnalysisBlueBIOMENCT07607158
Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites
A study testing Freeze-dried blueberry powder beverage in people with Microbiome Analysis and Metabolomics, run by Colorado State University at 1 site in United States.
Trial summary
The objective of this study is to determine whether inter-individual differences in the gut microbiome influence exposure to blueberry polyphenol metabolites. We will use pharmacokinetics of blueberry polyphenols after an acute blueberry exposure to group individuals into "metabotypes", groups of individuals based on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiome Analysis, Metabolomics
- What is being tested?
- Freeze-dried blueberry powder beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 1 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults ≥18 years of age
- Able and willing to provide informed consent
- Willing and able to adhere to all study procedures and visit requirements
Who cannot join
- Age <18 years
- Pregnant or breastfeeding
- Presence of chronic diseases, including but not limited to cardiovascular disease, diabetes, cancer, kidney, liver, gastrointestinal, or pancreatic disease
- Use of medications for chronic diseases that may interfere with study outcomes
- Any condition known to negatively impact nutrient absorption (e.g., inflammatory bowel disease, celiac disease, gastroparesis)
- Anemia (hemoglobin <13.5 g/dL in men or <12.0 g/dL in women)
Show all 12Show fewer
- Body mass index (BMI) ≤18.5 kg/m²
- Use of antibiotics within the past 2 months
- Recent blood draw within 1 week prior to study participation
- Currently participating in another research study involving a diet or exercise intervention
- Known allergy or contraindication to blueberry products or study procedures
- Unwilling or unable to comply with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado State University; Food and Nutrition Clinical Research Laboratory; Gifford Building Room 216; 502 West Lake Street, Fort Collins, CO 80523
Fort Collins, Colorado, 80523
Jenny Whittington, MS, 970-310-6843, ijwhitt@rams.colostate.edu
Tiffany Weir, PhD, Tiffany.weir@colostate.edu
About this study
The objective of this study is to determine whether inter-individual differences in the gut microbiome influence exposure to blueberry polyphenol metabolites. We will use pharmacokinetics of blueberry polyphenols after an acute blueberry exposure to group individuals into "metabotypes", groups of individuals based on similarity in their metabolite profiles. We will then use multi-omic approaches to determine whether the gut microbiome predicts an individual's metabotype.
Read the detailed description
This study is an acute, single-arm polyphenol pharmacokinetic study designed to evaluate inter-individual variability in the metabolism of blueberry polyphenols and the role of the gut microbiome in shaping these responses. The study will be conducted at Colorado State University in the Food \& Nutrition Clinical Research Laboratory. We will enroll approximately 125 healthy adults (≥18 years of age), with stratified recruitment across a range of ages and body mass index (BMI) values to capture diversity in gut microbiome composition. Participants will provide written informed consent prior to participation and will be compensated for their time.
Eligible participants will be generally healthy adults able to provide informed consent and adhere to study procedures. Key exclusion criteria include pregnancy or breastfeeding; pre-specified chronic diseases; recent antibiotic use; conditions affecting nutrient absorption; anemia; BMI ≤18.5 kg/m²; unwillingness to adhere to study protocols; recent blood draw within 1 week; participation in another research study; and contraindications to study procedures, treatments, or supplies.
The study consists of three main components: a screening visit, an acute test day, and a 24-hour follow-up visit. During the initial screening visit, participants will complete a health and medical history questionnaire, anthropometric assessments, blood pressure measurements, and a fasting blood draw to assess metabolic health and eligibility.
Following screening, participants will complete a short lead-in period prior to the test day, during which they will collect stool samples and a 24-hour urine sample at home and complete three 24-hour dietary recalls. They will also follow a low-polyphenol diet for three days prior to the test visit to minimize background variability in polyphenol exposure.
On the test day, participants will report to the laboratory following an overnight fast. Participants will consume a standardized blueberry beverage containing freeze-dried blueberry powder. Serial blood samples will be collected via an indwelling catheter at baseline and at multiple time points over an 8-hour period (0, 1, 2, 4, 6, and 8 hours) to characterize the pharmacokinetics of circulating blueberry polyphenol metabolites. Additional blood samples will be collected for peripheral blood mononuclear cell (PBMC) isolation at hours 4 and 6. Standardized low-polyphenol meals and snacks will be provided during the visit. Participants will also initiate a 24-hour urine collection and receive a stool collection kit for post-visit sampling.
Participants will return approximately 24 hours after blueberry consumption for a follow-up visit, which includes an additional fasting blood draw and return of urine and stool samples.
Throughout the study, additional data will be collected via validated questionnaires assessing gastrointestinal symptoms, sleep quality, physical activity, diet, and social determinants of health. Biological samples (blood, urine, and stool) will be used to assess polyphenol metabolism, gut microbiome composition and function, and related multi-omic profiles.
- Conditions
- Microbiome Analysis, Metabolomics
- Being tested
- Freeze-dried blueberry powder beverage
- Keywords
- Microbiome, Polyphenols, Metabotype, Pharmacokinetics, Metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried blueberry powder beverageOther
Participants will consume a single oral dose of a standardized blueberry beverage prepared with 22 g of freeze-dried blueberry powder reconstituted in approximately 480 mL of distilled water. The beverage will be consumed in its entirety at the start of the test visit following an overnight fast. This dose is selected to provide a defined quantity of blueberry-derived polyphenols for pharmacokinetic assessment. No additional interventions or comparator treatments will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | All participants will receive a single dose of the blueberry intervention to characterize pharmacokinetic profiles of polyphenol metabolites. Receives: Other: Freeze-dried blueberry powder beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Area under the curve (AUC) of circulating blueberry polyphenol metabolites
Pharmacokinetics - Area under the curve (AUC) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
Measured: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Pharmacokinetics - Maximum concentration (Cmax) of circulating blueberry polyphenol metabolites
Pharmacokinetics - Maximum concentration (Cmax) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
Measured: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Pharmacokinetics - Time to maximum concentration (Tmax) of circulating blueberry polyphenol metabolites
Pharmacokinetics - Time to maximum concentration (Tmax) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
Measured: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Secondary outcomes (5)
Urinary excretion of blueberry polyphenol metabolites
Urinary concentrations of blueberry-derived polyphenol metabolites will be measured via 24-hour urine collection to assess excretion profiles following a single-dose blueberry intervention.
Measured: up to 24 hours post-consumption
Gut microbial taxonomic profiling
16s rRNA gene amplicon sequencing of stool samples will be used for exploratory gut microbial taxonomic profiling.
Measured: Baseline
Gut microbial functional potential
Metagenomic shotgun sequencing of stool samples will be used for exploratory profiling of gut microbial functional potential.
Measured: Baseline
Gut microbial transcripts
Metatranscriptomics will be used for exploratory profiling of gut microbial transcripts.
Measured: Baseline
Polyphenol Metabotype
Machine learning methods will be used to determine participant polyphenol metabotypes from pharmacokinetic profiles.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start27 Jan 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome AnalysisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, acute polyphenol pharmacokinetic study
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University, National Center for Complementary and Integrative Health (NCCIH), University of Utah, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607158
- Sponsor's protocol ID
- 6959
- Other IDs
- 1RM1AT013318-01
- Acronym
- BlueBIOME
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites
- ClinicalTrials.gov ID
- NCT07607158
- Acronym / sponsor ID
- BlueBIOME / 6959
- Conditions
- Microbiome Analysis, Metabolomics
- Keywords
- Microbiome, Polyphenols, Metabotype, Pharmacokinetics, Metabolites
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Florida State University, National Center for Complementary and Integrative Health (NCCIH), University of Utah, King's College London
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 May 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.
The objective of this study is to determine whether inter-individual differences in the gut microbiome influence exposure to blueberry polyphenol metabolites. We will use pharmacokinetics of blueberry polyphenols after an acute blueberry exposure to group individuals into "metabotypes", groups of individuals based on similarity in their metabolite profiles. We will then use multi-omic approaches to determine whether the gut microbiome predicts an individual's metabotype.
Detailed description
This study is an acute, single-arm polyphenol pharmacokinetic study designed to evaluate inter-individual variability in the metabolism of blueberry polyphenols and the role of the gut microbiome in shaping these responses. The study will be conducted at Colorado State University in the Food \& Nutrition Clinical Research Laboratory. We will enroll approximately 125 healthy adults (≥18 years of age), with stratified recruitment across a range of ages and body mass index (BMI) values to capture diversity in gut microbiome composition. Participants will provide written informed consent prior to participation and will be compensated for their time.
Eligible participants will be generally healthy adults able to provide informed consent and adhere to study procedures. Key exclusion criteria include pregnancy or breastfeeding; pre-specified chronic diseases; recent antibiotic use; conditions affecting nutrient absorption; anemia; BMI ≤18.5 kg/m²; unwillingness to adhere to study protocols; recent blood draw within 1 week; participation in another research study; and contraindications to study procedures, treatments, or supplies.
The study consists of three main components: a screening visit, an acute test day, and a 24-hour follow-up visit. During the initial screening visit, participants will complete a health and medical history questionnaire, anthropometric assessments, blood pressure measurements, and a fasting blood draw to assess metabolic health and eligibility.
Following screening, participants will complete a short lead-in period prior to the test day, during which they will collect stool samples and a 24-hour urine sample at home and complete three 24-hour dietary recalls. They will also follow a low-polyphenol diet for three days prior to the test visit to minimize background variability in polyphenol exposure.
On the test day, participants will report to the laboratory following an overnight fast. Participants will consume a standardized blueberry beverage containing freeze-dried blueberry powder. Serial blood samples will be collected via an indwelling catheter at baseline and at multiple time points over an 8-hour period (0, 1, 2, 4, 6, and 8 hours) to characterize the pharmacokinetics of circulating blueberry polyphenol metabolites. Additional blood samples will be collected for peripheral blood mononuclear cell (PBMC) isolation at hours 4 and 6. Standardized low-polyphenol meals and snacks will be provided during the visit. Participants will also initiate a 24-hour urine collection and receive a stool collection kit for post-visit sampling.
Participants will return approximately 24 hours after blueberry consumption for a follow-up visit, which includes an additional fasting blood draw and return of urine and stool samples.
Throughout the study, additional data will be collected via validated questionnaires assessing gastrointestinal symptoms, sleep quality, physical activity, diet, and social determinants of health. Biological samples (blood, urine, and stool) will be used to assess polyphenol metabolism, gut microbiome composition and function, and related multi-omic profiles.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, acute polyphenol pharmacokinetic study
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Other: Freeze-dried blueberry powder beverageAll participants will receive a single dose of the blueberry intervention to characterize pharmacokinetic profiles of polyphenol metabolites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults ≥18 years of age
- Able and willing to provide informed consent
- Willing and able to adhere to all study procedures and visit requirements
Key exclusion criteria (12 listed)
- Age <18 years
- Pregnant or breastfeeding
- Presence of chronic diseases, including but not limited to cardiovascular disease, diabetes, cancer, kidney, liver, gastrointestinal, or pancreatic disease
- Use of medications for chronic diseases that may interfere with study outcomes
- Any condition known to negatively impact nutrient absorption (e.g., inflammatory bowel disease, celiac disease, gastroparesis)
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 |
|---|---|---|
| Freeze-dried blueberry powder beverageParticipants will consume a single oral dose of a standardized blueberry beverage prepared with 22 g of freeze-dried blueberry powder reconstituted in approximately 480 mL of distilled water. The beverage will be consumed in its entirety at the start of the test visit following an overnight fast. This dose is selected to provide a defined quantity of blueberry-derived polyphenols for pharmacokinetic assessment. No additional interventions or comparator treatments will be administered. | Other | Single-arm |
Primary outcome
Pharmacokinetics - Area under the curve (AUC) of circulating blueberry polyphenol metabolites
Time frame: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Pharmacokinetics - Area under the curve (AUC) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
Pharmacokinetics - Maximum concentration (Cmax) of circulating blueberry polyphenol metabolites
Time frame: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Pharmacokinetics - Maximum concentration (Cmax) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
Pharmacokinetics - Time to maximum concentration (Tmax) of circulating blueberry polyphenol metabolites
Time frame: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption
Pharmacokinetics - Time to maximum concentration (Tmax) will be calculated from plasma concentrations of blueberry-derived polyphenol metabolites, measured at serial time points following a single-dose blueberry intervention.
5 secondary outcomes
Urinary excretion of blueberry polyphenol metabolites
Time frame: up to 24 hours post-consumption
Gut microbial taxonomic profiling
Time frame: Baseline
Gut microbial functional potential
Time frame: Baseline
Gut microbial transcripts
Time frame: Baseline
Polyphenol Metabotype
Time frame: Baseline
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 26 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried blueberry powder beverage in people with Microbiome Analysis and Metabolomics, run by Colorado 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 12 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 26 May 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 Tiffany Weir, PhD ((970) 491-4631, tiffany.weir@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Area under the curve (AUC) of circulating blueberry polyphenol metabolites (time frame: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption). The study lists 3 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 26 May 2026.