How gut microbes affect blueberry polyphenol metabolites in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an acute, single-arm pharmacokinetic study conducted at Colorado State University to explore how individual gut microbiomes shape the metabolism of blueberry polyphenols. Approximately 125 healthy adults will ingest a freeze-dried blueberry powder beverage, with blood and possibly other samples collected on a test day and a 24-hour follow-up to assess metabolite exposure. Participants will be stratified into metabotypes based on metabolite profiles and then analyzed with multi-omic approaches to see if the gut microbiome predicts these metabotypes. The study includes screening, an acute test day, and a follow-up visit, with careful eligibility criteria to exclude factors that could confound metabolism. Outcomes focus on pharmacokinetics of blueberry polyphenol metabolites and correlations with gut microbiome composition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Where it's running

• Colorado State University; Food and Nutrition Clinical Research Laboratory; Gifford Building Room 216; 502 West Lake Street, Fort Collins, CO 80523
  Fort Collins, Colorado, United States Recruiting

Study contacts

• Study coordinator: Tiffany Weir, PhD
• Email: tiffany.weir@colostate.edu
• Phone: (970) 491-4631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.