NCT07607158 · Colorado State University
Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites
(BlueBIOME)
What this study is about
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 how the drug moves through the body of blueberry polyphenols after an acute blueberry exposure to group individuals into "metabotypes", groups of individuals based on similarity in their metabolite profiles.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Fort Collins, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations