Glucose Metabolism Disorders
Conditions
Brief summary
The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.
Interventions
DIETARY_SUPPLEMENTBerberine Phytosome
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fasting blood glucose range:100-125 mg/dl
Exclusion criteria
* Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on insulin resistance | Changes from baseline insulin resistance at 4 weeks and at 8 weeks | Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2,4 |
| Changes on carbohydrate profile | Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks | Fasting Glucose (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on anthropometry | Changes from baseline anthropometry at 4 weeks and at 8 weeks | Weight (Kg) |
| Changes on body composition | Changes from baseline body composition at 4 weeks and at 8 weeks | Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g) |
| Changes on lipid profile | Changes from baseline lipid profile at 4 weeks and at 8 weeks | Total Cholesterol (mg/dl), High density lipoprotein Cholesterol (mg/dl), Low density lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl), Apolipoprotein A (mg/dl), Apolipoprotein B (mg/dl) |
| Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks | Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l) |
Countries
Italy
Contacts
Primary ContactMariangela Rondanelli
Outcome results
None listed