Dysglycemia, Dyslipidemias
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTBerberol® K
Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of LDL cholesterol | 12 months | Reduction of LDL-cholesterol after the nutraceutical or placebo intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of lipid profile | 12 months | Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake |
| Change in glycemic status | 12 months | To evaluate the number of subjects changing from impaired fasting glucose or impaired glucose tolerance to type 2 diabetes mellitus |
Countries
Italy
Contacts
Primary ContactGiuseppe Derosa
Outcome results
None listed