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临床试验/NCT06347094
NCT06347094招募中不适用

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

University of Parma4 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2024年4月22日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
330
试验地点
4
主要终点
Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Metabotypes will also be masked to participants and investigators, while the dietary treatment will not.

入排标准

年龄范围
40 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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

结局指标

主要结局

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

时间窗: 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 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).

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

时间窗: 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 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).

次要结局

  • 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))
  • 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))
  • 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))
  • 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))
  • Biomarkers of cardiometabolic health: insulin(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))
  • Inflammatory status(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))
  • Biomarkers of cardiometabolic health: hematochemical and urine analysis(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))
  • Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase(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))
  • Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance(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))
  • Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Hard Coronary Heart Disease - 10-years risk(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Atherosclerotic Cardiovascular Disease(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Biomarkers of cardiometabolic health: homocysteine(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))
  • Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function(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))
  • Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Framingham Heart Study for Fatty Liver Disease(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index(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))
  • Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome(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))
  • Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin(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))
  • Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index(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))
  • Risk prediction scores: First Coronary Heart Disease - 2-years risk(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Framingham Heart Study for Diabetes(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Framingham Heart Study for Stroke(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Framingham Heart Study for Hypertension(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: QRESEARCH risk estimator version 3(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: QDiabetes Score(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Nutritional and energy assessment: LARN(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))
  • Lifestyle factors assessment: sleep quality (PSQI)(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))
  • Lifestyle factors assessment: state of health (BDI)(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))
  • Lifestyle factors assessment: state of health (SF-36)(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))
  • (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes(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))
  • Gut microbiota composition(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Finnish Diabetes Risk Score(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Risk prediction scores: Cuore Project - Calculating the individual risk score(Visit 3 (after 8 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index(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))
  • Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index(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))
  • Lifestyle factors assessment: general information(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))
  • Genetic differences(Visit 3 (after 8 weeks from the beginning of the study))
  • Evaluation of adherence to healthy and sustainable dietary models: DASH Index(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))
  • Evaluation of adherence to Mediterranean diet(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))
  • Nutritional and energy assessment: EPIC(Visit 2 (after 4 weeks from the beginning of the study) and Visit 5 (after 24 weeks from the beginning of the study))
  • Lifestyle factors assessment: sleep quality (ISI)(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))
  • Lifestyle factors assessment: physical activity (IPAQ)(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))
  • Biomarkers of food intake and of healthy dietary patterns(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))
  • Untargeted metabolomics(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))
  • Biomarkers of adipose tissue function(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))
  • Lifestyle factors assessment: sleep quality (ESS)(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))
  • Other plant bioactive metabolites(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))
  • Oral microbiota composition(Visit 5 (after 24 weeks from the beginning of the study))
  • Biomarkers of food intake regulation(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))
  • Food/gut/host-derived metabolites(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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro M. Mena Parreño

PhD

University of Parma

研究点 (4)

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