Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome

NCT07505277 | Recruiting

• 1 other identifier: CARISMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Functional foods; Nutritional intervantion

Outcome Measures

Primary Outcomes (1)

• Changes in postprandial glycemia

  PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

Pre-post design

EXPERIMENTAL

Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks

Other: Mediterranean diet and Mediterranean diet + functional foods

Interventions

Mediterranean diet and Mediterranean diet + functional foods OTHER

1. PHASE: Mediterranean diet for 8 weeks 2. PHASE: Mediterranean diet + functional foods for 8 weeks

Pre-post design

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals with metabolic syndrome
• Continuous pharmacological treatments for dysmetabolic conditions
• BMI \<18.5 kg/m² or \>35 kg/m²
• Glycated hemoglobin (HbA1c) \> 6%
• Pregnancy

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead
• Bonvicini Clinic: collaborator

Study Sites (1)

Bonvicini Clinic

Bolzano, Bolzano, 39100, Italy

RECRUITING

Related Publications (2)

• 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)

  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.

  PMID: 40722902 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Mediterranean; Functional Food

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food; Food and Beverages

Central Study Contacts

Prof. Lucio Lucchin

CONTACT

+39 0471 442700; veronica.marin@drschaer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 1, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)