Recruiting

PPPILPolyphenol Metabotype Characterization in Type 2 Diabetes Patients

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Study Aim

This study aims to observe and characterize the overall polyphenol metabotype in your urine, 24 hours after ingesting a polyphenol-rich pill, comparing individuals with type 2 diabetes to healthy age-matched individuals without diabetes.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 40 to 85 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2026
See protocol details

Summary

Principal SponsorUniversity Hospital, Ghent
Study ContactJan Stautemas, PhDMore contacts
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 4, 2026

Actual date on which the first participant was enrolled.

The study focuses on understanding the overall 'polyphenol metabotype' in people with Type 2 Diabetes Mellitus (T2DM) and comparing it to those without diabetes. Polyphenols are natural compounds found in foods like fruits, vegetables, and tea. The 'metabotype' refers to the unique pattern of these compounds in the body after they have been processed. The study also aims to identify factors, such as gut microbial capacity and transit time, that might influence this metabotype. This research is important as it could provide insights into how dietary polyphenols may impact diabetes management and overall health in individuals with T2DM. Participants in this observational study will consume a pill rich in polyphenols. The study will then analyze the morning urine samples collected 24 hours after consuming the pill. The primary outcome is to find differences in polyphenol metabolites, or breakdown products, in the urine of people with T2DM and healthy individuals. This approach allows the study to characterize the polyphenol metabotype in both groups and compare them.

Official TitlePolyphenol Metabotypes in People With Diabetes Type 2
NCT06810635
Principal SponsorUniversity Hospital, Ghent
Study ContactJan Stautemas, PhDMore contacts
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

8 inclusion criteria required to participate
all participants

between 40-85 years

age-matched individuals without diabetes

BMI between 18.5-30

Show More Criteria

18 exclusion criteria prevent from participating
pregnancy of breastfeeding

in last month

acute use of anti/pre/probiotics

start of new drug or dietary supplements

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Department of rehabilitation sciences - UGent

Ghent, BelgiumOpen Department of rehabilitation sciences - UGent in Google Maps
Recruiting soon

Ghent University

Ghent, Belgium
Recruiting
2 Study Centers
PPPIL | Polyphenol Metabotype Characterization in Type 2 Diabetes Patients | PatLynk