Berberine and Altered Fasting Glucose

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031715
• Other study ID #: ID 0912/14122018
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

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