Metabolic SyndromeNCT07505277
Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome
A study testing Mediterranean diet and Mediterranean diet + functional foods in people with Metabolic Syndrome, run by Dr. Schär AG / SPA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Mediterranean diet and Mediterranean diet + functional foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with metabolic syndrome
- Continuous pharmacological treatments for dysmetabolic conditions
- BMI <18.5 kg/m² or >35 kg/m²
- Glycated hemoglobin (HbA1c) > 6%
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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:
Read more
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
- Being tested
- Mediterranean diet and Mediterranean diet + functional foods
- Keywords
- Metabolic Syndrome, Functional foods, Nutritional intervantion
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet and Mediterranean diet + functional foodsOther
- PHASE: Mediterranean diet for 8 weeks
- PHASE: Mediterranean diet + functional foods for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pre-post design | Experimental | Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks Receives: Other: Mediterranean diet and Mediterranean diet + functional foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postprandial glycemia
Measured: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Secondary outcomes (4)
Changes in BMI
Measured: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in body composition
Measured: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in serum lipid profile
Measured: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Changes in serum oxidative related metabolomics
Measured: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Schär AG / SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bonvicini Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505277
- Sponsor's protocol ID
- CARISMA
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.jcs.2025.104351. (https://www.sciencedirect.com/science/article/pii/S0733521025002504)
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.
PubMed 40722902
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07505277
- Acronym / sponsor ID
- CARISMA
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Functional foods, Nutritional intervantion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Schär AG / SPAIndustry (pharma, biotech, devices)
- Collaborators
- Bonvicini Clinic
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-post design | Experimental | Other: Mediterranean diet and Mediterranean diet + functional foodsStandard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Individuals with metabolic syndrome
- Continuous pharmacological treatments for dysmetabolic conditions
- BMI <18.5 kg/m² or >35 kg/m²
- Glycated hemoglobin (HbA1c) > 6%
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet and Mediterranean diet + functional foods1. PHASE: Mediterranean diet for 8 weeks 2. PHASE: Mediterranean diet + functional foods for 8 weeks | Other | Pre-post design |
Primary outcome
Changes in postprandial glycemia
Time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Results publicationAndrea 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)
- Results publication: PubMed 40722902Cardone 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.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Mediterranean diet + functional foods in people with Metabolic Syndrome, run by Dr. Schär AG / SPA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Lucio Lucchin (+39 0471 442700, veronica.marin@drschaer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postprandial glycemia (time frame: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07505277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.