Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColorado State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Freeze-dried blueberry powder beverage
Other interventionParticipants 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.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Single-armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption2
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.
Time frame
Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumption3
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.
Time frame
Baseline and 1, 2, 4, 6, 8 and 24 hours post-consumptionSecondary outcomes
1
Urinary excretion of blueberry polyphenol metabolites
Urinary concentrations of blueberry-derived polyphenol metabolites will be measured via 24-hour urine collection to assess excretion profiles following a single-dose blueberry intervention.
Time frame
up to 24 hours post-consumption2
Gut microbial taxonomic profiling
16s rRNA gene amplicon sequencing of stool samples will be used for exploratory gut microbial taxonomic profiling.
Time frame
Baseline3
Gut microbial functional potential
Metagenomic shotgun sequencing of stool samples will be used for exploratory profiling of gut microbial functional potential.
Time frame
Baseline4
Gut microbial transcripts
Metatranscriptomics will be used for exploratory profiling of gut microbial transcripts.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
Florida State University
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
University of Utah
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov