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

University of Pavia

Status: Enrolling

Conditions: Dyslipidemias; Dysglycemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Berberol® K

Study type: Interventional

Funder types: Other

Identifiers

NCT06348550

BFMKP 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Active treatment

Active Comparator group

Treatment:

Dietary Supplement: Berberol® K

Placebo treatment

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo