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

NCT ID: NCT06347094

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2025-12-31

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.

Conditions

Individual Variability in (Poly)Phenol Metabolism; Cardiometabolic Health; Personalized Dietary Intervention; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Metabotype X, Treatment

Subjects belonging to a specific aggregate phenolic metabotype (X) to which a diet with an increase of 50% in the actual (poly)phenol intake will be given, through personalized dietary plans.

Group Type: EXPERIMENTAL

Personalized Dietary Plan

Intervention Type: OTHER

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

Oral (Poly)phenol Challenge Test (OPCT)

Intervention Type: DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

Metabotype X, Control

Subjects belonging to a specific aggregate phenolic metabotype (X) to which general dietary recommendations for a healthy diet will be given.

Group Type: EXPERIMENTAL

Oral (Poly)phenol Challenge Test (OPCT)

Intervention Type: DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

General Dietary Advice

Intervention Type: OTHER

Prescription of balanced dietary plans

Metabotype Y, Treatment

Subjects belonging to a specific aggregate phenolic metabotype (Y) to which a diet with an increase of 50% in the actual (poly)phenol intake will be given, through personalized dietary plans.

Group Type: EXPERIMENTAL

Personalized Dietary Plan

Intervention Type: OTHER

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

Oral (Poly)phenol Challenge Test (OPCT)

Intervention Type: DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

Metabotype Y, Control

Subjects belonging to a specific aggregate phenolic metabotype (X) to which general dietary recommendations for a healthy diet will be given.

Group Type: EXPERIMENTAL

Oral (Poly)phenol Challenge Test (OPCT)

Intervention Type: DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

General Dietary Advice

Intervention Type: OTHER

Prescription of balanced dietary plans

Interventions

Personalized Dietary Plan

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

Intervention Type: OTHER

Oral (Poly)phenol Challenge Test (OPCT)

Nutritional challenge with standardized (poly)phenol-rich tablets

Intervention Type: DIETARY_SUPPLEMENT

General Dietary Advice

Prescription of balanced dietary plans

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (40-80 y.o.)
• Non-clinically diagnosed for cardiometabolic diseases at baseline examination
• At least one of the following risk factors: overweight or obese, central obesity (waist:hip ratio > 0.90 in males and > 0.85 in females or waist circumference ≥ 94 cm in males and ≥ 80 cm in females), hypertension (systolic BP > 130 or diastolic BP > 85 mm Hg), low high-density lipoprotein cholesterol levels (< 40 mg/dL (1.03 mmol/L) in males, < 50 mg/dL (1.29 mmol/L) in females), or elevated total cholesterol (≥ 200 mg/dL), low-density lipoprotein cholesterol (≥ 130 mg/dL (4.1 mmol/L)), triglyceride (> 150 mg/dL (1.7 mmol/L)), fasting glucose (> 100 mg/dL (5.6 mmol/L)) levels, or microalbuminuria (urinary albumin excretion ratio ≥ 20 μg/min or albumin:creatinine ratio ≥ 30 mg/g).

Exclusion Criteria

• BMI < 18.5 or > 34.9 kg/m²
• Past cardiovascular events and metabolic diseases including diabetes
• Inflammatory bowel diseases or gastro-intestinal surgery (other than appendectomy)
• Cholecystectomy within the past 5 years
• Renal or hepatic diseases
• Levels of estimated Glomerular Filtration (eGFR) < 60 mL/min/1.73 m²
• Aspartate transaminase (AST)/alanine aminotransferase (ALT) 2.5 times the upper limits of normal
• Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)
• Mental disorders
• Hormone therapy (other than that used for hypothyroidism, birth-control or menopause symptoms)
• Antibiotic therapy within the last month before the study
• Food allergies associated with the consumption of plant foods or foods that will be provided in the study
• Difficulties or major inconveniences in changing dietary habits or adhering to a plant-based Mediterranean-type diet
• Presence of chewing or swallowing disorders
• Pregnancy or lactation

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

Foundation for Liver Research

OTHER

Sponsor Role: collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: lead

Responsible Party

Pedro M. Mena Parreño

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro M Mena Parreño, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

University of Parma - Plesso Biotecnologico Integrato

Parma, PR, Italy

Site Status: RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pedro M Mena Parreño, PhD

Role: CONTACT

pedromiguel.menaparreno@unipr.it

+39 0521 903970

Maria Sole Morandini, MSc

Role: CONTACT

mariasole.morandini@unipr.it

+39 0521902043

Facility Contacts

Pedro M Mena Parreño, PhD

Role: primary

pedromiguel.menaparreno@unipr.it

+39 0521 903970

Joana M Santos Rebelo, MSc

Role: backup

joanamaria.santosrebelo@unipr.it

+39 0521902043

Riccardo Bonadonna, MD

Role: primary

riccardo.bonadonna@unipr.it

+39 0521 033307

Other Identifiers

610/2023/SPER/UNIPR

Identifier Type: -

Identifier Source: org_study_id