Berberine and Altered Fasting Glucose

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Assumption of a Berberine Phytosoma-based Supplement on the Hematic Values of Glucose in a Group of Patients With Altered Fasting Glucose

Conditions
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Glucose Metabolism Disorders

Intervention / Treatment
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* Dietary Supplement: Berberine Phytosome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting blood glucose range:100-125 mg/dl Exclusion Criteria: Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>Berberine Phytosome | Dietary Supplement: Berberine Phytosome<br>* 2 tablets of 550 mg per day (1 before lunch and 1 before dinner)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |