Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT)

NCT05414084 | Completed

• 1 other identifier: 1352/2020/SPER/UNIPR
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a single-dose acute clinical trial aiming at identifying aggregate metabolic phenotypes for the main dietary (poly)phenols and assessing the factors associated with their formation. The treatment consists of a nutritional challenge representative of the consumption of (poly)phenols in Europeans (so-called oral (poly)phenol challenge test, OPCT) and foresees the supplementation of three standardized tablets rich in (poly)phenols, prepared from various commercially available plant extracts constituting sources of specific (poly)phenols. Urinary excretion of (poly)phenol metabolites will be evaluated at 24 hours after tablet consumption or, for two subgroups of volunteers, at different time points for 24 hours upon tablet consumption. Blood pressure and heart rate will also be measured and anthropometric data collected. Information will be collected on genetic polymorphisms related to the metabolism of (poly)phenols, gene expression, standard cardiometabolic health biomarkers, cardiometabolic risk scores and gut microbiota profile, through the collection of urine, blood and stool samples. Volunteers will follow a (poly)phenol-free diet before and after the OPCT. To check compliance with food restrictions, a 24-hour recall will be carried out on each visit. For a sub-group of 50 subjects, 3 months after the first challenge, the OPCT will be repeated with further urinary and fecal collection.

Conditions

Individual Variability in (Poly)Phenol Metabolism; Cardiometabolic Health

Keywords

intervention study; (poly)phenols; metabolic phenotypes; metabotypes; cardiometabolic diseases; inter-individual variability; phenolic metabolites

Outcome Measures

Primary Outcomes (1)

• Identification of aggregate phenolic metabotypes

  Assessing the variability in the urinary excretion of phenolic metabolites among volunteers after consumption of (poly)phenol-rich tablets by using data-driven clustering.

  24 hours post-consumption

Secondary Outcomes (14)

• Assessing common cardiometabolic health biomarkers in blood samples

  Baseline

• Assessing risk prediction scores

  Baseline

• Evaluating trimethylamine N-oxide (TMAO) in urine and plasma samples

  Baseline

• Evaluating eicosanoids in urine samples

  Baseline

• Assessing DNA oxidation catabolites and branched fatty acyl esters of hydroxyl fatty acids (FAHFAs) in plasma samples

  Baseline

Study Arms (1)

(Poly)phenol tablets

EXPERIMENTAL

Single ingestion of 3 tablets containing different amounts of the most representative dietary (poly)phenols (i.e. flavonoid subclasses, phenolic acids, lignans, ellagitannins, stilbenes, flavonols, procyanidins and phenylethanoids)

Dietary Supplement: Oral (poly)phenol challenge test (OPCT)

Interventions

Oral (poly)phenol challenge test (OPCT) DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

(Poly)phenol tablets

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18-74 y)
• BMI 18.5-35 kg/m\^2

You may not qualify if:

• Past cardiovascular events and metabolic diseases including diabetes
• Inflammatory bowel diseases or gastro-intestinal surgery
• Renal (GFR\<60 ml/min) or hepatic diseases (liver enzymes \>2.5 fold higher)
• Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)
• Mental disorders
• Antibiotic therapy within the last month
• Food allergies
• Pregnancy or lactation

Sponsors & Collaborators

• University of Parma: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• University of Birmingham: collaborator
• National Research Council, Spain: collaborator

Study Sites (2)

University of Parma - Plesso Biotecnologico Integrato

Parma, PR, 43125, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, 43126, Italy

Location

Study Officials

• Pedro M Mena Parreño, PhD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 10, 2022
• Study Start: May 31, 2022
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: April 27, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)