Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean diet and Mediterranean diet + functional foods.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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
Interventions
- Other Mediterranean diet and Mediterranean diet + functional foods
1. PHASE: Mediterranean diet for 8 weeks 2. PHASE: Mediterranean diet + functional foods for 8 weeks
Primary outcome measures
- Changes in postprandial glycemia [Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8]
Secondary outcome measures (4)
- Changes in BMI [Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8]
- Changes in body composition [Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8]
- Changes in serum lipid profile [Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8]
- Changes in serum oxidative related metabolomics [Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Bonvicini Clinic — Bolzano
Publications
- Andrea Pichler, Serena Foria, Martina Magni, Veronica Marin, Manuel Pramsohler, Gaetano Cardone, Peter Robatscher, Silvano Ciani, Ombretta Polenghi, Virna Lucia Cerne, Michael Oberhuber, Comparative analysis of health-promoting nutrients in oat cultivars from Alpine production versus commercial origin, Journal of Cereal Science, Volume 127, 2026, 104351, ISSN 0733-5210, https://doi.org/10.1016/j.j
- Cardone G, Magni M, Marin V, Pichler A, Zatelli D, Robatscher P, Polenghi O, Cerne VL, Oberhuber M, Ciani S. Upcycling of By-Products from Autochthonous Red Grapes and Commercial Apples as Ingredients in Baked Goods: A Comprehensive Study from Processing to Consumer Consumption. Antioxidants (Basel). 2025 Jun 27;14(7):798. doi: 10.3390/antiox14070798. PMID 40722902
Identifiers
NCT: NCT07505277 · CARISMA