Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites

NCT07607158 | Recruiting

• 2 other identifiers: 69591RM1AT013318-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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 similarity in their metabolite profiles. We will then use multi-omic approaches to determine whether the gut microbiome predicts an individual's metabotype.

Conditions

Microbiome Analysis; Metabolomics

Keywords

Microbiome; Polyphenols; Metabotype; Pharmacokinetics; Metabolites

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption

Secondary Outcomes (5)

• Urinary excretion of blueberry polyphenol metabolites

  up to 24 hours post-consumption

• Gut microbial taxonomic profiling

  Baseline

• Gut microbial functional potential

  Baseline

• Gut microbial transcripts

  Baseline

• Polyphenol Metabotype

  Baseline

Study Arms (1)

Single-arm

EXPERIMENTAL

All participants will receive a single dose of the blueberry intervention to characterize pharmacokinetic profiles of polyphenol metabolites.

Other: Freeze-dried blueberry powder beverage

Interventions

Freeze-dried blueberry powder beverage OTHER

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.

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• Florida State University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Utah: collaborator
• King's College London: collaborator

Study Sites (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, 80523, United States

RECRUITING

Central Study Contacts

Tiffany Weir, PhD

CONTACT

(970) 491-4631; tiffany.weir@colostate.edu

Jenny Whittington, MS

CONTACT

(970) 310-6843; ijwhitt@rams.colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, acute polyphenol pharmacokinetic study

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 26, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)