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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05031715
Other study ID # ID 0912/14122018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date July 25, 2022

Study information

Verified date August 2021
Source Azienda di Servizi alla Persona di Pavia
Contact Mariangela Rondanelli
Phone +390382381749
Email mariangela.rondanelli@unipv.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 25, 2022
Est. primary completion date May 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Fasting blood glucose range:100-125 mg/dl Exclusion Criteria: - Diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Berberine Phytosome
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)

Locations

Country Name City State
Italy Mariangela Rondanelli Pavia

Sponsors (1)

Lead Sponsor Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Changes on carbohydrate profile Fasting Glucose (mg/dl) Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Primary Changes on carbohydrate profile Glycated hemoglobin (%) Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Secondary Changes on anthropometry Weight (Kg) Changes from baseline anthropometry at 4 weeks and at 8 weeks
Secondary Changes on anthropometry Body Mass Index (Kg/m2) Changes from baseline anthropometry at 4 weeks and at 8 weeks
Secondary Changes on anthropometry Waist circumference (cm) Changes from baseline anthropometry at 4 weeks and at 8 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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