About this trial
The goal of this clinical trial is to evaluate whether introducing specific functional foods into the diet of individuals at risk of developing metabolic syndrome leads to improvements in key metabolic and oxidative health parameters.
The main questions it aims to answer are:
Does the consumption of these functional foods reduce post-prandial glycemia? Does daily intake of these formulations improve other health indicators such as body weight, body composition, lipid profile, and oxidative metabolomic markers?
The functional food formulations used in this study include:
A blend of multifunctional ingredients derived from apple and grape by-products Added prebiotic fibers (inulin) Oat β-glucans Omega-3 fatty acids
Participants will:
Consume the assigned functional food formulations daily Attend regular clinic visits for physiological measurements and blood tests Undergo assessments of body composition, serum lipids, and serum metabolomics
Primary Study Objective:
Variation in post-prandial glycemia
Secondary Objectives:
Reduction in BMI Changes in body composition Changes in serum lipid profile Changes in serum oxidative-related metabolomics
Eligibility criteria
Qualifiers
Age between 18 and 60 years
Individuals who do not have metabolic syndrome
Impaired glucose tolerance (IGT) (≥100 mg/dL), or borderline hypertension (systolic 120-139 mmHg, diastolic 80-90 mmHg), or mild hypercholesterolemia (200-239 mg/dL)
Absence of any long-term pharmacological treatment for diabetes, hypertension, dyslipidemia, hyperuricemia, or other chronic conditions
Disqualifiers
Individuals with metabolic syndrome
Continuous pharmacological treatments for dysmetabolic conditions
BMI <18.5 kg/m² or >35 kg/m²
Glycated hemoglobin (HbA1c) > 6%
Trial design
Treatments tested in this trial
- Mediterranean diet and Mediterranean diet + functional foods
Treatment groups
Sponsors and collaborators
Dr. Schär AG / SPA
Lead sponsor
Bonvicini Clinic
Collaborator