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

NCT06347094 | Recruiting

• 1 other identifier: 610/2023/SPER/UNIPR
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

nutritional intervention study; personalized nutrition; cardiometabolic risk; obesity; (poly)phenols; metabotypes; inter-individual variability; food-gut-host interactions; predictive models

Outcome Measures

Primary Outcomes (2)

• Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation

  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).

  Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

• Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons

  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).

  Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

Secondary Outcomes (52)

• Anthropometric measurements: weight, height and body mass index

  Visit 1 (at the beginning of the study), Visit 3 (after 8 weeks from the beginning of the study), Visit 4 (after 16 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

• Anthropometric measurements: waist and hip circumferences detection

  Visit 1 (at the beginning of the study), Visit 3 (after 8 weeks from the beginning of the study), Visit 4 (after 16 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

• Body composition: bioelectrical impedance analysis

  Visit 1 (at the beginning of the study), Visit 3 (after 8 weeks from the beginning of the study), Visit 4 (after 16 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

• Blood pressure

  Visit 1 (at the beginning of the study), Visit 3 (after 8 weeks from the beginning of the study), Visit 4 (after 16 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

• Heart rate

  Visit 1 (at the beginning of the study), Visit 3 (after 8 weeks from the beginning of the study), Visit 4 (after 16 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)

Study Arms (4)

Metabotype X, Treatment

EXPERIMENTAL

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.

Other: Personalized Dietary Plan; Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Metabotype X, Control

EXPERIMENTAL

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

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT); Other: General Dietary Advice

Metabotype Y, Treatment

EXPERIMENTAL

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.

Other: Personalized Dietary Plan; Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Metabotype Y, Control

EXPERIMENTAL

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

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT); Other: General Dietary Advice

Interventions

Personalized Dietary Plan 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

Metabotype X, Treatment; Metabotype Y, Treatment

Oral (Poly)phenol Challenge Test (OPCT) DIETARY_SUPPLEMENT

Nutritional challenge with standardized (poly)phenol-rich tablets

Metabotype X, Control; Metabotype X, Treatment; Metabotype Y, Control; Metabotype Y, Treatment

General Dietary Advice OTHER

Prescription of balanced dietary plans

Metabotype X, Control; Metabotype Y, Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• University of Milan: collaborator
• Foundation for Liver Research: collaborator
• National Research Council, Spain: collaborator

Study Sites (2)

University of Parma - Plesso Biotecnologico Integrato

Parma, PR, 43125, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, 43126, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro M Mena Parreño, PhD

  University of Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro M Mena Parreño, PhD

CONTACT

+39 0521 903970; pedromiguel.menaparreno@unipr.it

Maria Sole Morandini, MSc

CONTACT

+39 0521902043; mariasole.morandini@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Metabotypes will also be masked to participants and investigators, while the dietary treatment will not.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 4, 2024
• Study Start: April 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)