Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome

Single-arm, Pre-Post Clinical Trial on the Effect of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome.

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

Inclusion Criteria:

• Age between 18 and 60 years
• Individuals who do not have metabolic syndrome
• Presence of abdominal circumference >94 cm for men or >80 cm for women, or a body mass index (BMI) between 25 and 34.9 kg/m², and at least two of the following parameters:
• 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

Exclusion Criteria:

• Individuals with metabolic syndrome
• Continuous pharmacological treatments for dysmetabolic conditions
• BMI <18.5 kg/m² or >35 kg/m²
• Glycated hemoglobin (HbA1c) > 6%
• Pregnancy