Individual Variability in (Poly)Phenol MetabolismOPCTNCT05414084
Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT)
A study testing Oral (poly)phenol challenge test (OPCT) in people with Individual Variability in (Poly)Phenol Metabolism and Cardiometabolic Health, run by University of Parma at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Individual Variability in (Poly)Phenol Metabolism, Cardiometabolic Health
- What is being tested?
- Oral (poly)phenol challenge test (OPCT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 31 May 2022to 26 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18-74 y)
- BMI 18.5-35 kg/m^2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Parma - Plesso Biotecnologico Integrato
Parma, PR, 43125
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126
About this study
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)
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.
- Being tested
- Oral (poly)phenol challenge test (OPCT)
- Keywords
- intervention study, (poly)phenols, metabolic phenotypes, metabotypes, cardiometabolic diseases, inter-individual variability, phenolic metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral (poly)phenol challenge test (OPCT)Dietary supplement
Nutritional challenge with standardized (poly)phenol-rich tablets
| Study group | Role | What they receive |
|---|---|---|
| (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) Receives: Dietary Supplement: Oral (poly)phenol challenge test (OPCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-consumption
Secondary outcomes (14)
Assessing common cardiometabolic health biomarkers in blood samples
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.
Measured: Baseline
Assessing risk prediction scores
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.
Measured: Baseline
Evaluating trimethylamine N-oxide (TMAO) in urine and plasma samples
TMAO will be quantified in baseline urine and fasting plasma samples by UHPLC-MS/MS.
Measured: Baseline
Evaluating eicosanoids in urine samples
Eicosanoids, including prostaglandins, thromboxanes, leukotrienes, isoprostanes and neuroprostanes will be evaluated in baseline urine samples (0-h) by UHPLC-QqQ-MS/MS.
Measured: Baseline
Assessing DNA oxidation catabolites and branched fatty acyl esters of hydroxyl fatty acids (FAHFAs) in plasma samples
DNA oxidation catabolites and FAHFAs will be measured in fasting plasma samples by UHPLC-QqQ-MS/MS.
Measured: Baseline
Determining genetic differences among subjects
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.
Measured: Baseline
Assessing transcriptomic signatures in peripheral blood mononuclear cells (PBMCs).
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.
Measured: Baseline
Determining gut microbiota composition and functionality in fecal samples
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).
Measured: Baseline
Assessing dietary habits
Dietary habits will be assessed through a food frequency questionnaire.
Measured: Baseline
Assessing anthropometric measurements
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).
Measured: Baseline
Assessing blood pressure and heart rate
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.
Measured: Baseline
Evolution over the time of the phenolic metabolites in urine samples
Assessed by using UHPLC-MS/MS for individual detection and quantification.
Measured: Different collection times for 24 hours (0; 0-3; 3-6; 6-9; 9-12; 12-24; 24 h)
Untargeted urinary metabolomics
The untargeted LC-IMS-MS metabolomics approach will allow to assess potential differences among the metabolomes of individuals belonging to different aggregate phenolic metabotypes.
Measured: Baseline and 24 hours post-consumption
Assessing the stability of aggregate phenolic metabotypes among individuals after 3 months
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.
Measured: 24 hours post-consumption in a test carried out after 3 months after the first supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start31 May 2022
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individual Variability in (Poly)Phenol MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Parma, University of Birmingham, National Research Council, Spain
- Responsible party
- Principal investigator, Pedro M. Mena Parreño, University of Parma
- Investigators
- Pedro M Mena Parreño, PhD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414084
- Sponsor's protocol ID
- 1352/2020/SPER/UNIPR
- Acronym
- OPCT
- Status last verified
- Feb 2024
- First submitted
- 26 May 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05414084
- Acronym / sponsor ID
- OPCT / 1352/2020/SPER/UNIPR
- Keywords
- intervention study, (poly)phenols, metabolic phenotypes, metabotypes, cardiometabolic diseases, inter-individual variability, phenolic metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Parma, University of Birmingham, National Research Council, Spain
- Study start
- 31 May 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Poly)phenol tablets | Experimental | Dietary Supplement: Oral (poly)phenol challenge test (OPCT)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) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (18-74 y)
- BMI 18.5-35 kg/m^2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral (poly)phenol challenge test (OPCT)Nutritional challenge with standardized (poly)phenol-rich tablets | Dietary supplement | (Poly)phenol tablets |
Primary outcome
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.
14 secondary outcomes
Assessing common cardiometabolic health biomarkers in blood samples
Time frame: Baseline
Assessing risk prediction scores
Time frame: Baseline
Evaluating trimethylamine N-oxide (TMAO) in urine and plasma samples
Time frame: Baseline
Evaluating eicosanoids in urine samples
Time frame: Baseline
Assessing DNA oxidation catabolites and branched fatty acyl esters of hydroxyl fatty acids (FAHFAs) in plasma samples
Time frame: Baseline
Determining genetic differences among subjects
Time frame: Baseline
Assessing transcriptomic signatures in peripheral blood mononuclear cells (PBMCs).
Time frame: Baseline
Determining gut microbiota composition and functionality in fecal samples
Time frame: Baseline
Assessing dietary habits
Time frame: Baseline
Assessing anthropometric measurements
Time frame: Baseline
Assessing blood pressure and heart rate
Time frame: Baseline
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)
Untargeted urinary metabolomics
Time frame: Baseline and 24 hours post-consumption
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Active, not recruiting
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Overweight and Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro M Mena Parreño, PhD principal investigator
University of Parma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral (poly)phenol challenge test (OPCT) in people with Individual Variability in (Poly)Phenol Metabolism and Cardiometabolic Health, run by University of Parma at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of aggregate phenolic metabotypes (time frame: 24 hours post-consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.