Recruiting

Blueberry Polyphenols

Sponsor:

Colorado State University

Code:

NCT07607158

Conditions

Microbiome Analysis

Metabolomics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Freeze-dried blueberry powder beverage

Study Details

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

Study ID

NCT07607158

Start date

Jan 27, 2026

Status verified date

May, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single-arm

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

Interventions

Freeze-dried blueberry powder beverage

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.

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 ]
  • Pharmacokinetics - Maximum concentration (Cmax) 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) of circulating blueberry polyphenol metabolites [ Time Frame: Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption ]

Central Contacts and Locations

Central contacts

Tiffany Weir, PhD

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

Jenny Whittington, MS

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

Locations

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

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Jenny Whittington, MS

970-310-6843ijwhitt@rams.colostate.edu

Tiffany Weir, PhD

Tiffany.weir@colostate.edu

Principal Investigator:

Tiffany Weir, PhD

More Information

Sponsor

Colorado State University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Microbiome
  • Polyphenols
  • Metabotype
  • Pharmacokinetics
  • Metabolites

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2026-05-26.