Berberine and Altered Fasting Glucose

Not Applicable

• Conditions: Glucose Metabolism Disorders

• Registration Number: NCT05031715
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Primary Completion: 2020-05-28
• Status Verified: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Fasting blood glucose range:100-125 mg/dl

Exclusion Criteria

• Diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes on carbohydrate profile	Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks	Glycated hemoglobin (%)
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

Secondary Outcome Measures

Name	Time	Method
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	Glomerural Filtrate Rate (ml/min)
Changes on anthropometry	Changes from baseline anthropometry at 4 weeks and at 8 weeks	Waist circumference (cm)

Trial Locations

Locations (1)

Mariangela Rondanelli; 🇮🇹 Pavia, Italy