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

Dyslipidemias Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348550
• Other study ID #: BFMKP 01
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: University of Pavia
• Contact: Giuseppe Derosa
• Phone: +390382502614
• Email: giuseppe.derosa[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysglycemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Berberol® K
Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Matteo Foundation	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
University of Pavia	Foundation IRCCS San Matteo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of LDL cholesterol	Reduction of LDL-cholesterol after the nutraceutical or placebo intake	12 months
Secondary	Variation of lipid profile	Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake	12 months
Secondary	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