Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07607158

Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites

Led by Colorado State University · Updated on 2026-05-26

125

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

C

Colorado State University

Lead Sponsor

F

Florida State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how differences in the gut microbiome affect how people's bodies process blueberry polyphenols. This study aims to categorize individuals into groups called "metabotypes" based on their metabolite profiles after consuming blueberries. The goal is to see if the gut microbiome can predict these metabotypes using advanced multi-omic techniques. Participants will consume a single dose of a standardized blueberry beverage made from 22 grams of freeze-dried blueberry powder mixed in water after fasting overnight. The study includes a screening visit, a test day with blood sampling over 8 hours, and a 24-hour follow-up visit. During the test day, blood samples will be collected at multiple times to track blueberry polyphenol metabolites, and standardized low-polyphenol meals will be provided. Participants will also collect stool and urine samples before and after the test day. Throughout the study, participants will complete questionnaires on diet, physical activity, sleep quality, gastrointestinal symptoms, and social health factors. Biological samples including blood, urine, and stool will be analyzed to study polyphenol metabolism and gut microbiome features. The main measurements include the area under the curve, maximum concentration, and time to maximum concentration of blueberry polyphenol metabolites in the blood. The study is expected to last from screening through a 24-hour follow-up, with compensation for participants' time.

CONDITIONS

Brief Title

Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults 18 years of age or older
  • Able and willing to provide informed consent
  • Willing and able to follow all study procedures and visit requirements
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding
  • Chronic diseases such as cardiovascular disease, diabetes, cancer, kidney, liver, gastrointestinal, or pancreatic disease
  • Use of medications for chronic diseases that may affect study outcomes
  • Conditions affecting nutrient absorption (e.g., inflammatory bowel disease, celiac disease, gastroparesis)
  • Anemia (hemoglobin below 13.5 g/dL in men or below 12.0 g/dL in women)
  • Body mass index (BMI) 18.5 kg/m2 or lower
  • Antibiotic use within the past 2 months
  • Recent blood draw within 1 week before participation
  • Participation in another diet or exercise research study
  • Known allergy or contraindication to blueberry products or study procedures
  • Unwilling or unable to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Lead-in Period

Duration - Approximately 1 week

Participants collect stool and 24-hour urine samples at home, complete dietary recalls, and follow a low-polyphenol diet for three days prior to the test visit.

Home sample collections and dietary recalls

Treatment

Duration - 1 day

Participants consume a standardized blueberry beverage after an overnight fast. Serial blood samples are collected over 8 hours, and standardized meals are provided. Participants initiate 24-hour urine collection and receive a stool collection kit for post-visit sampling.

1 visit (in-person) with multiple blood draws over 8 hours

Follow-up

Duration - 1 day

Participants return approximately 24 hours after blueberry consumption for a fasting blood draw and to return urine and stool samples.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

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, 80523

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Research Team

T

Tiffany Weir, PhD

J

Jenny Whittington, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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