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

March 26, 2026 updated by: Dr. Schär AG / SPA

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Bolzano
      • Bolzano, Bolzano, Italy, 39100
        • Recruiting
        • Bonvicini Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-post design
Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks
Other: Mediterranean diet and Mediterranean diet + functional foods
  1. PHASE: Mediterranean diet for 8 weeks
  2. PHASE: Mediterranean diet + functional foods for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in BMI
Time Frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in body composition
Time Frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in serum lipid profile
Time Frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in serum oxidative related metabolomics
Time Frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Schär AG / SPA

Collaborators

Bonvicini Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARISMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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