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RECRUITING
NCT07505277
NA

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

Sponsor: Dr. Schär AG / SPA

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-01

Completion Date

2027-06

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

OTHER

Mediterranean diet and Mediterranean diet + functional foods

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

Locations (1)

Bonvicini Clinic

Bolzano, Bolzano, Italy