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

Last updated: March 31, 2024
Sponsor: University of Pavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Berberol® K

Clinical Study ID

NCT06348550
BFMKP 01
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 glucoseor impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
  • Total cholesterol values ≥ 200 mg/dl

Exclusion

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 Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
November 30, 2023
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • IRCCS Policlinico S. Matteo Foundation

    Pavia, 27100
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.