Functional foods with antioxidants, prebiotic fiber, oat beta‑glucan and omega‑3 for people at risk of metabolic syndrome

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.

This trial will test whether daily functional foods containing antioxidants, prebiotic fiber, oat beta‑glucan, and omega‑3s can lower post-meal blood sugar and improve weight, lipids, and oxidative markers in adults at risk for metabolic syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Dr. Schär AG / SPA (Industry-sponsored)
• Locations: 1 site (Bolzano, Bolzano)
• Trial ID: NCT07505277 on ClinicalTrials.gov

What this trial studies

Adults at risk for metabolic syndrome are assigned to follow a Mediterranean diet alone or a Mediterranean diet plus daily functional food formulations that combine apple and grape by‑products, inulin, oat β‑glucan, and omega‑3 fatty acids. Participants consume the assigned foods daily and attend regular clinic visits at the Bonvicini Clinic for physiological measurements and blood draws. Outcomes include post‑prandial glycemia, body weight and composition, serum lipid profile, and metabolomic markers of oxidative stress. The trial excludes people with established metabolic syndrome, significant chronic medication use for metabolic conditions, extreme BMI values, very high HbA1c, or pregnancy.

Who should consider this trial

Good fit: Adults aged 18–60 who do not yet have metabolic syndrome but have abdominal obesity or BMI 25–34.9 kg/m² plus at least two risk features (impaired fasting glucose, borderline blood pressure, or mild hypercholesterolemia) and are not on chronic metabolic medications.

Not a fit: People who already have metabolic syndrome, are pregnant, have BMI <18.5 or >35 kg/m², HbA1c >6%, or are on continuous pharmacologic treatment for diabetes, hypertension, or dyslipidemia are unlikely to benefit from this prevention-focused intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce post‑meal glucose spikes, improve body composition and lipid levels, and lower oxidative stress, potentially delaying or preventing progression to metabolic syndrome.

How similar studies have performed: Previous trials of isolated components such as oat β‑glucan, prebiotic fibers, and omega‑3s have shown modest improvements in glycemia, lipids, and inflammatory markers, but combinations like this specific formulation remain less well studied.

Eligibility criteria

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

Where this trial is running

Bolzano, Bolzano

• Bonvicini Clinic — Bolzano, Bolzano, Italy (Recruiting)

Study contacts

• Study coordinator: Prof. Lucio Lucchin

Conditions Metabolic Syndrome; Functional foods; Nutritional intervantion