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NCT05414084: OPCT
Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT)
NA trial testing Oral (poly)phenol challenge test (OPCT) in Individual Variability in (Poly)Phenol Metabolism in 300 participants. Completed in 26 May 2023.
26 May 2023
Quick facts
| Lead sponsor | University of Parma |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 300 |
| Start date | 31 May 2022 |
| Primary completion | 26 May 2023 |
| Estimated completion | 26 May 2023 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Oral (poly)phenol challenge test (OPCT)
Conditions studied
- Individual Variability in (Poly)Phenol Metabolism — all drugs for Individual Variability in (Poly)Phenol Metabolism →
- Cardiometabolic Health — all drugs for Cardiometabolic Health →
Sponsor
University of Parma
Who can join
Adults 18 to 74, any sex, with Individual Variability in (Poly)Phenol Metabolism or Cardiometabolic Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05414084
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Individual Variability in (Poly)Phenol Metabolism
Currently open trials in the same condition.
- NCT06347094 — Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols · NA · recruiting
- NCT06028659 — Investigation of in Vivo Endogenous and/or Exogenous Production of Phenolic Metabolites Using (un)Targeted Metabolomics · NA · recruiting
Other University of Parma trials
Trials by the same sponsor.
- NCT07242079 — Effect Of Pulmonary Rehabilitation in Patients With Alpha-1 Antitrypsin Deficiency · completed
- NCT06977802 — Design and Implementation of a Mobile App for Promoting Healthy and Sustainable Eating Among Students at the University · NA · completed
- NCT06347094 — Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols · NA · recruiting
- NCT06028659 — Investigation of in Vivo Endogenous and/or Exogenous Production of Phenolic Metabolites Using (un)Targeted Metabolomics · NA · recruiting
- NCT06455956 — Use of miRNAs in Growth Hormone Deficiency (GHD) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05414084 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Parma
- Last refreshed: 27 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05414084.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing