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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®
Placebo
IRCCS Policlinico S. Matteo Foundation
Pavia, Italy
RECRUITINGVariation of LDL cholesterol
Reduction of LDL-cholesterol after the nutraceutical or placebo intake
Time frame: 12 months
Variation of lipid profile
Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake
Time frame: 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
Time frame: 12 months
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