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

University of Parma

Status: Completed

Conditions: Cardiometabolic Health; Individual Variability in (Poly)Phenol Metabolism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05414084

1352/2020/SPER/UNIPR

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

(Poly)phenol tablets

Experimental group

Description:

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)

Treatment:

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