Clinical trial NCT06347094: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Official title: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Parma
name: University of Milan
name: Foundation for Liver Research
name: National Research Council, Spain
First posted: 2024-04-04
Enrollment: 330
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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

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)
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)
Secondary outcomes:
measure: Anthropometric measurements: weight, height and body mass index
timeFrame: 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)
measure: Anthropometric measurements: waist and hip circumferences detection
timeFrame: 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)
measure: Body composition: bioelectrical impedance analysis
timeFrame: 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)
measure: Blood pressure
timeFrame: 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)
measure: Heart rate
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: hematochemical and urine analysis
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: homocysteine
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: insulin
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function
timeFrame: 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)
measure: Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance
timeFrame: 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)
measure: Inflammatory status
timeFrame: 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)
measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Hard Coronary Heart Disease - 10-years risk
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: First Coronary Heart Disease - 2-years risk
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Framingham Heart Study for Diabetes
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Framingham Heart Study for Hypertension
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Framingham Heart Study for Stroke
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Framingham Heart Study for Fatty Liver Disease
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Atherosclerotic Cardiovascular Disease
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: QRESEARCH risk estimator version 3
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: QDiabetes Score
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Finnish Diabetes Risk Score
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Risk prediction scores: Cuore Project - Calculating the individual risk score
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Evaluation of adherence to healthy and sustainable dietary models: DASH Index
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Evaluation of adherence to Mediterranean diet
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Nutritional and energy assessment: LARN
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Nutritional and energy assessment: EPIC
timeFrame: Visit 2 (after 4 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome
timeFrame: Visit 2 (after 4 weeks from 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)
measure: Lifestyle factors assessment: general information
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: sleep quality (PSQI)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: sleep quality (ESS)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: sleep quality (ISI)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: physical activity (IPAQ)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: state of health (BDI)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: Lifestyle factors assessment: state of health (SF-36)
timeFrame: Visit 1 (beginning of the study), Visit 2 (4 weeks after the beginning of the study) Visit 3 (8 weeks after the beginning of the study), Visit 4 (16 weeks after the beginning of the study) and Visit 5 (24 weeks after the beginning of the study)
measure: (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes
timeFrame: 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)
measure: Other plant bioactive metabolites
timeFrame: 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)
measure: Food/gut/host-derived metabolites
timeFrame: 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)
measure: Biomarkers of food intake and of healthy dietary patterns
timeFrame: 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)
measure: Untargeted metabolomics
timeFrame: 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)
measure: Genetic differences
timeFrame: Visit 3 (after 8 weeks from the beginning of the study)
measure: Gut microbiota composition
timeFrame: Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study)
measure: Oral microbiota composition
timeFrame: Visit 5 (after 24 weeks from the beginning of the study)
measure: Biomarkers of adipose tissue function
timeFrame: 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)
measure: Biomarkers of food intake regulation
timeFrame: 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)
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma - Plesso Biotecnologico Integrato
state: PR
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
Study officials:
affiliation: University of Parma
name: Pedro M Mena Parreño, PhD
role: PRINCIPAL_INVESTIGATOR
References: