Functional foods with antioxidants, prebiotic fiber, oat beta‑glucan and omega‑3 for people at risk of metabolic syndrome
Official 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.
Run by Dr. Schär AG / SPA · NCT07505277 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Dr. Schär AG / SPA Industry-sponsored |
| Locations | 1 site (Bolzano, Bolzano) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | February 2027 |
| Study ends | June 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07505277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Bonvicini Clinic
Bolzano, Bolzano, Italy Recruiting
Study contacts
- Study coordinator: Prof. Lucio Lucchin
- Email: veronica.marin@drschaer.com
- Phone: +39 0471 442700
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fulvic acid supplements for metabolic syndrome
This study tests whether 50 mg or 100 mg of fulvic acid daily for 12 weeks can help people with metabolic syndrome or prediabetes.
-
Asprosin and miRNA Profiles in Young Women with Metabolic Syndrome
This study tests whether certain blood biomarkers, including asprosin and six microRNAs, differ between young women with metabolic syndrome and healthy peers.
-
Using Multimodal Ultrasound to Check Muscle Mass in Metabolic Disease Patients
This study tests whether a multimodal ultrasound approach can accurately measure muscle mass in people with metabolic syndrome, obesity, sarcopenia, or type 2 diabetes.
-
Low-Calorie Diet in adolescents with Familial Mediterranean Fever and metabolic syndrome
A group of adolescents with both FMF and metabolic syndrome will try a low-calorie diet for 3 months to see if it helps manage metabolic symptoms.
-
Exercise for Metabolic Syndrome and Fatty Liver in Adolescent Girls with Celiac Disease
This study tests whether a 3-month walking program helps improve metabolic syndrome and fatty liver in adolescent females with celiac disease.
-
Longevity Metrics AI/ML Development Study
Researchers are testing AI models that score health screening tests and predict outcomes like life expectancy for adults, using ongoing follow-up data.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.