Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (NCT06347094) | Clinical Trial Compass
UnknownNot Applicable
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Italy330 participantsStarted 2024-04-22
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)