Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.

Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. Single-center, Randomized, Double-blind Study.

The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; Dysglycemia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Berberol® K

Detailed Description

The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Derosa; Phone Number: +390382502614; Email: giuseppe.derosa@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS Policlinico S. Matteo Foundation
    • Sub-Investigator: Pamela Maffioli, MD
    • Principal Investigator: Giuseppe Derosa, MD, PhD
    • Contact: Giuseppe Derosa, MD, PhD; Email: giuseppe.derosa@unipv.it
    • Contact: Pamela Maffioli, MD; Email: p.maffioli@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Overweight or obese subjects [according to body mass index (BMI)]
• 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 neoplastic and liver diseases, renal failure
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo treatment	Dietary supplement: Placebo; Placebo
Active Comparator: Active treatment	Dietary supplement: Berberol® K; Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of LDL cholesterol	Reduction of LDL-cholesterol after the nutraceutical or placebo intake	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of lipid profile	Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake	12 months
Change in glycemic status	To evaluate the number of subjects changing from impaired fasting glucose or impaired glucose tolerance to type 2 diabetes mellitus	12 months

Collaborators and Investigators

• Sponsor: University of Pavia
• Collaborators: Foundation IRCCS San Matteo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: BFMKP 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No