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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Experimental | Berberine Phytosome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine Phytosome | Dietary Supplement | 2 tablets of 550 mg per day (1 before lunch and 1 before dinner) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes on insulin resistance | Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2,4 | Changes from baseline insulin resistance at 4 weeks and at 8 weeks |
| Changes on carbohydrate profile | Fasting Glucose (mg/dl) | Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks |
| Changes on carbohydrate profile | Glycated hemoglobin (%) | Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on anthropometry | Weight (Kg) | Changes from baseline anthropometry at 4 weeks and at 8 weeks |
| Changes on anthropometry | Body Mass Index (Kg/m2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariangela Rondanelli | Contact | +390382381749 | mariangela.rondanelli@unipv.it |
| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli | Fondazione Casemiro Mondino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mariangela Rondanelli | Recruiting | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Changes from baseline anthropometry at 4 weeks and at 8 weeks |
| Changes on anthropometry | Waist circumference (cm) | Changes from baseline anthropometry at 4 weeks and at 8 weeks |
| Changes on body composition | Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g) | Changes from baseline body composition at 4 weeks and at 8 weeks |
| Changes on lipid profile | 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 from baseline lipid profile at 4 weeks and at 8 weeks |
| Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l) | Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks |
| Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Gamma Glutamyl Transferase (U/l) | Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks |
| Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Creatinine (mg/dl) | Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks |
| Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Glomerural Filtrate Rate (ml/min) | Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks |