Overview
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.
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