Berberine and Altered Fasting Glucose
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Dietary supplement Berberine Phytosome |
Dietary Supplement: Berberine Phytosome
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
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Outcome Measures
Primary Outcome Measures
- 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)
- Changes on carbohydrate profile [Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks]
Glycated hemoglobin (%)
Secondary Outcome Measures
- Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]
Weight (Kg)
- Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]
Body Mass Index (Kg/m2)
- Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]
Waist circumference (cm)
- 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)
- 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]
Gamma Glutamyl Transferase (U/l)
- 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]
Creatinine (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]
Glomerural Filtrate Rate (ml/min)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fasting blood glucose range:100-125 mg/dl
Exclusion Criteria:
- Diabetes mellitus
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mariangela Rondanelli | Pavia | Italy | 27100 |
Sponsors and Collaborators
- Azienda di Servizi alla Persona di Pavia
Investigators
- Principal Investigator: Mariangela Rondanelli, Fondazione Casemiro Mondino
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID 0912/14122018