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Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

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Studies 94
Trials 51
Recruiting NA INTERVENTIONAL NCT06347094

Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping.

Detailed Description

The recruitment will be carried out to prospectively include 330 subjects belonging to two aggregate phenolic metabotypes, that will be compared in the intervention part (1:1). To do so, a maximum of 500 subjects at cardiometabolic risk will be screened following an oral (poly)phenol challenge test (OPCT). In the observational phase, eating habits and lifestyle data will be collected, and these will serve as a run-in for the experimental phase. In the experimental phase, two-thirds of the participants within each metabotype will be randomly allocated to the treatment arm: 50% increase in the (poly)phenol intake, with a minimum daily intake of 500 mg. Treatment allocation shifts minimally the dietary habits of treated participants to allow causal explanations. No changes in the (poly)phenol intake will be asked to the control arm, composed of one-third of the subjects in each metabotype. Blood pressure and heart rate will also be measured and anthropometric data collected. Information will be accessed on cardiometabolic risk scores, cardiometabolic health biomarkers, inflammatory markers, hormones, metabolism of food components, genetic polymorphisms, gut and saliva microbiota profile, etc., through the collection of saliva, urine, blood, and stool samples.

Interventions

Name: Personalized Dietary Plan
Type: OTHER
Description: Prescription of dietary plans increasing the intake of (poly)phenols through consumption of foods rich in these compounds, in the context of a balanced, personalised diet
Name: Oral (Poly)phenol Challenge Test (OPCT)
Type: DIETARY_SUPPLEMENT
Description: Nutritional challenge with standardized (poly)phenol-rich tablets
Name: General Dietary Advice
Type: OTHER
Description: Prescription of balanced dietary plans

Primary Outcomes

Measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation
TimeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
Description: Assessing the effect of a (poly)phenol-rich diet on 10-year risk of cardiovascular disease using the Systematic Coronary Risk Estimation (SCORE2) for volunteers aged between 40 and 69 years, considering different aggregate phenolic metabotypes. Interpretation of the result depends on the patient's age as the cut-off risk levels are numerically different for various age groups: low-moderate Cardiovascular Disease (CVD) risk (\< 2.5% for \< 50 years; \< 5% for 50-69 years), high CVD risk (2.5% to \< 7.5% for \< 50 years; 5% to \< 10% for 50-69 years), very high CVD risk (≥ 7.5% for \< 50 years; ≥ 10% for 50-69 years).
Measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons
TimeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
Description: Assessing the effect of a (poly)phenol-rich diet on 10-year risk of cardiovascular disease using the Systematic Coronary Risk Estimation-Older Persons (SCORE2-OP) for volunteers aged between 70 and 89 years, considering different aggregate phenolic metabotypes. Interpretation of the result depends on the patient's age as the cut-off risk levels are numerically different for various age groups: low-moderate CVD risk (\< 7.5% for ≥ 70 years), high CVD risk (7.5% to \< 15% for ≥ 70 years ), very high CVD risk (≥ 15% for ≥ 70 years).

Trial Information

NCT ID

NCT06347094

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

University of Parma

Last Updated

December 15, 2025