Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-28 @ 3:12 AM
Study NCT ID:
NCT06347094
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Sponsor:
University of Parma
Organization:
Study Overview
Official Title:
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-CARE-DIET
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: