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.
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Bonvicini Clinic
RECRUITING
Bolzano
Contact Information
Primary
Prof. Lucio Lucchin
veronica.marin@drschaer.com
+39 0471 442700
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 40
Treatments
Experimental: Pre-post design
Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Dr. Schär AG / SPA
Collaborators: Bonvicini Clinic