Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)

University of Parma

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06347094

610/2023/SPER/UNIPR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

330 participants in 4 patient groups

Metabotype X, Treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Other: Personalized Dietary Plan

Metabotype X, Control

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Other: General Dietary Advice

Metabotype Y, Treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Other: Personalized Dietary Plan

Metabotype Y, Control

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral (Poly)phenol Challenge Test (OPCT)

Other: General Dietary Advice