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NCT Number: NCT07505277

Study of the Effects 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

Recruiting

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bonvicini Clinic

Bolzano, 39100, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet and Mediterranean diet + functional foods

Other
  • PHASE: Mediterranean diet for 8 weeks
  • PHASE: Mediterranean diet + functional foods for 8 weeks

Primary outcomes

  1. Changes in postprandial glycemia

    Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

Secondary outcomes

  1. Changes in BMI

    Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

  2. Changes in body composition

    Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

  3. Changes in serum lipid profile

    Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

  4. Changes in serum oxidative related metabolomics

    Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Lucio Lucchin

CONTACT

[email protected]

+39 0471 442700

Sponsors and collaborators

Lead sponsor

Dr. Schär AG / SPA

Industry

Collaborators

  • Bonvicini Clinic

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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