Clinical trial NCT05414084: Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT)
Official title: Identification of Aggregate Metabolic Phenotypes for the Main Dietary (Poly)Phenols and Assessment of the Factors Associated With Their Formation: Development of an Oral (Poly)Phenol Challenge Test (OPCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individual Variability in (Poly)Phenol Metabolism
Cardiometabolic Health
Keywords: intervention study
(poly)phenols
metabolic phenotypes
metabotypes
cardiometabolic diseases
inter-individual variability
phenolic metabolites
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Parma
name: University of Birmingham
name: National Research Council, Spain
First posted: 2022-06-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Identification of aggregate phenolic metabotypes
timeFrame: 24 hours post-consumption
Secondary outcomes:
measure: Assessing common cardiometabolic health biomarkers in blood samples
timeFrame: Baseline
measure: Assessing risk prediction scores
timeFrame: Baseline
measure: Evaluating trimethylamine N-oxide (TMAO) in urine and plasma samples
timeFrame: Baseline
measure: Evaluating eicosanoids in urine samples
timeFrame: Baseline
measure: Assessing DNA oxidation catabolites and branched fatty acyl esters of hydroxyl fatty acids (FAHFAs) in plasma samples
timeFrame: Baseline
measure: Determining genetic differences among subjects
timeFrame: Baseline
measure: Assessing transcriptomic signatures in peripheral blood mononuclear cells (PBMCs).
timeFrame: Baseline
measure: Determining gut microbiota composition and functionality in fecal samples
timeFrame: Baseline
measure: Assessing dietary habits
timeFrame: Baseline
measure: Assessing anthropometric measurements
timeFrame: Baseline
measure: Assessing blood pressure and heart rate
timeFrame: Baseline
measure: Evolution over the time of the phenolic metabolites in urine samples
timeFrame: Different collection times for 24 hours (0; 0-3; 3-6; 6-9; 9-12; 12-24; 24 h)
measure: Untargeted urinary metabolomics
timeFrame: Baseline and 24 hours post-consumption
measure: Assessing the stability of aggregate phenolic metabotypes among individuals after 3 months
timeFrame: 24 hours post-consumption in a test carried out after 3 months after the first supplementation
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma - Plesso Biotecnologico Integrato
state: PR
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
Study officials:
affiliation: University of Parma
name: Pedro M Mena Parreño, PhD
role: PRINCIPAL_INVESTIGATOR
References: