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
Study ID
NCT07505277
Status
Recruiting
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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Apr 1, 2026
Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-post design
    Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks

Primary Outcome Measure

Changes in postprandial glycemia [ Time Frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 ]

Central Contacts

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