Actively Recruiting
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Led by University of Parma · Updated on 2024-05-10
330
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
Sponsors
U
University of Parma
Lead Sponsor
A
Azienda Ospedaliero-Universitaria di Parma
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 80 years
- No clinical diagnosis of cardiometabolic diseases at baseline
- Have at least one risk factor: overweight or obesity, central obesity (waist:hip ratio > 0.90 in males or > 0.85 in females, or waist circumference ≥ 94 cm in males or ≥ 80 cm in females), hypertension (systolic BP > 130 mm Hg or diastolic BP > 85 mm Hg), low HDL cholesterol (< 40 mg/dL in males, < 50 mg/dL in females), or elevated total cholesterol (≥ 200 mg/dL), LDL cholesterol (≥ 130 mg/dL), triglycerides (> 150 mg/dL), fasting glucose (> 100 mg/dL), or microalbuminuria (urinary albumin excretion ratio ≥ 20 µg/min or albumin:creatinine ratio ≥ 30 mg/g)
You will not qualify if you...
- Body mass index (BMI) less than 18.5 or greater than 34.9 kg/m²
- History of cardiovascular events or metabolic diseases including diabetes
- Inflammatory bowel diseases or gastrointestinal surgery other than appendectomy
- Gallbladder removal surgery within the past 5 years
- Kidney or liver diseases
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m²
- Elevated liver enzymes (AST or ALT more than 2.5 times the upper normal limit)
- Immunodeficiency or autoimmune diseases except well-controlled hypothyroidism
- Mental disorders
- Hormone therapy except for hypothyroidism, birth control, or menopause symptoms
- Antibiotic treatment within the month before the study
- Food allergies related to plant foods or foods provided in the study
- Significant difficulties or major problems in changing diet or following a plant-based Mediterranean diet
- Chewing or swallowing disorders
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Parma - Plesso Biotecnologico Integrato
Parma, PR, Italy, 43125
Actively Recruiting
2
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy, 43126
Actively Recruiting
Research Team
P
Pedro M Mena Parreño, PhD
CONTACT
M
Maria Sole Morandini, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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