NCT07505277 Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome
| NCT ID | NCT07505277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Schär AG / SPA |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07505277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07505277 currently recruiting?
Yes, NCT07505277 is actively recruiting participants. Contact the research team at veronica.marin@drschaer.com for enrollment information.
Where is the NCT07505277 trial being conducted?
This trial is being conducted at Bolzano, Italy.
Who is sponsoring the NCT07505277 clinical trial?
NCT07505277 is sponsored by Dr. Schär AG / SPA. The trial plans to enroll 40 participants.