Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.
NCT ID: NCT06348550
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active treatment
Berberol® K
Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®
Placebo treatment
Placebo
Placebo
Interventions
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Berberol® K
Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
* Total cholesterol values ≥ 200 mg/dl
Exclusion Criteria
* Patients with type 1 or 2 diabetes mellitus
* Pregnant or breastfeeding women
* Hypersensitivity to any of the ingredients
* Therapy with lipid-lowering drugs
* Use of products containing red yeast rice
18 Years
70 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
University of Pavia
OTHER
Responsible Party
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Giuseppe Derosa
Principal Investigator
Locations
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IRCCS Policlinico S. Matteo Foundation
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BFMKP 01
Identifier Type: -
Identifier Source: org_study_id
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