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Completed

NCT Number: NCT05414084

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

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.

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Key information

Conditions

Individual Variability in (Poly)Phenol Metabolism Cardiometabolic Health

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria di Parma, Parma, PR, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral (poly)phenol challenge test (OPCT)

Dietary Supplement

Nutritional challenge with standardized (poly)phenol-rich tablets

Primary outcomes

  1. Identification of aggregate phenolic metabotypes

    Time frame: 24 hours post-consumption

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

Secondary outcomes

  1. Assessing common cardiometabolic health biomarkers in blood samples

    Time frame: Baseline

    Samples will be processed for the analysis of common biomarkers of cardiometabolic health: total cholesterol (mg/dL), HDL-cholesterol (mg/dL), triglycerides (mg/dL), glucose (mg/dL), insuline (uUI/mL). Analyses will follow standardised routine procedures.

  2. Assessing risk prediction scores

    Time frame: Baseline

    Risk prediction scores (i.e., Framingham General Cardiovascular Risk Score, Framingham Heart Study Primary Risk Functions for heart disease, stroke, diabetes, fatty liver disease, and hypertension, Atherosclerotic Cardiovascular Disease (ASCVD) Risk, QRISK3®, QDScore®, Finnish Diabetes Risk Score (FINDRISC)) will be assessed to understand their relationship with the aggregate phenolic metabotypes observed. The higher the scores, the worse the risk of developing the disease.

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

    Time frame: Baseline

    TMAO will be quantified in baseline urine and fasting plasma samples by UHPLC-MS/MS.

  4. Evaluating eicosanoids in urine samples

    Time frame: Baseline

    Eicosanoids, including prostaglandins, thromboxanes, leukotrienes, isoprostanes and neuroprostanes will be evaluated in baseline urine samples (0-h) by UHPLC-QqQ-MS/MS.

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

    Time frame: Baseline

    DNA oxidation catabolites and FAHFAs will be measured in fasting plasma samples by UHPLC-QqQ-MS/MS.

  6. Determining genetic differences among subjects

    Time frame: Baseline

    Genotyping will be conducted using genome wide, SNP array approach untargeted methodology, using commercially available SNP arrays and a tSNP approach. This approach will involve the genotyping of approximately 300 SNPs. Genomic DNA will be prepared from PBMCs isolated from blood samples.

  7. Assessing transcriptomic signatures in peripheral blood mononuclear cells (PBMCs).

    Time frame: Baseline

    Specific patterns of gene expression related to each metabotype will be investigated in PBMCs by using a microarray-based approach. Analysis will be carried out in a subset of 10 samples for each metabotype.

  8. Determining gut microbiota composition and functionality in fecal samples

    Time frame: Baseline

    Microbial profiling will be assessed by shallow shotgun metagenomics. Full shotgun metagenomics analysis will be carried out to determine functional pathways in a sample subset (50 samples).

  9. Assessing dietary habits

    Time frame: Baseline

    Dietary habits will be assessed through a food frequency questionnaire.

  10. Assessing anthropometric measurements

    Time frame: Baseline

    Weight and height will be combined to report BMI in kg/m^2 and this will be carried out according to standardized procedures. Waist circumference and hip circumference, waist-to-height ratio, waist-to-hip ratio, and body composition measurement (skinfold test and bioelectrical impedance analysis).

  11. Assessing blood pressure and heart rate

    Time frame: Baseline

    Systolic and diastolic blood pressure and heart rate of each volunteer will be obtained after a 5-min rest in a seated position in the baseline visit.

  12. Evolution over the time of the phenolic metabolites in urine samples

    Time frame: Different collection times for 24 hours (0; 0-3; 3-6; 6-9; 9-12; 12-24; 24 h)

    Assessed by using UHPLC-MS/MS for individual detection and quantification.

  13. Untargeted urinary metabolomics

    Time frame: Baseline and 24 hours post-consumption

    The untargeted LC-IMS-MS metabolomics approach will allow to assess potential differences among the metabolomes of individuals belonging to different aggregate phenolic metabotypes.

  14. Assessing the stability of aggregate phenolic metabotypes among individuals after 3 months

    Time frame: 24 hours post-consumption in a test carried out after 3 months after the first supplementation

    Assessing the variability in the urinary excretion of phenolic metabolites among volunteers after consumption of (poly)phenol-rich tablets, considering the metabotype to which each volunteer belongs to once the volunteer re-do the oral (poly)phenol challenge test after 3 months from the first supplementation.

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

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

Registry information

Official study 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)

Acronym: OPCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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