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| Name | Class |
|---|---|
| Bonvicini Clinic | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-post design | Experimental | Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet and Mediterranean diet + functional foods | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in postprandial glycemia | PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in BMI | PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 | |
| Changes in body composition | PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Lucio Lucchin | Contact | +39 0471 442700 | veronica.marin@drschaer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonvicini Clinic | Recruiting | Bolzano | Bolzano | 39100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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.jcs.2025.104351. (https://www.sciencedirect.com/science/article/pii/S0733521025002504) | ||
| 40722902 | Result | 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. |
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| Changes in serum lipid profile |
| PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 |
| Changes in serum oxidative related metabolomics | PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D055951 | Functional Food |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005502 | Food |
| D019602 | Food and Beverages |
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