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

ConditionMetabolic Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorDr. Schär AG / SPA

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Pre-post designExperimental treatment 1 intervention