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

Condition(s) studied

Investigational drug(s) / intervention(s)

Mediterranean diet and Mediterranean diet + functional foods: 1. PHASE: Mediterranean diet for 8 weeks 2. PHASE: Mediterranean diet + functional foods for 8 weeks

Study summary

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

Primary outcome measure(s)

• Changes in postprandial glycemia — PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

Trial sites (1)

Other trials for the same condition