Berberine and Altered Fasting Glucose

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Berberine Phytosome

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariangela Rondanelli; Phone Number: +390382381749; Email: mariangela.rondanelli@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Mariangela Rondanelli
    • Contact: Mariangela Rondanelli; Phone Number: 0382381749; Email: mariangela.rondanelli@unipv.it
    • Contact: Mariangela Rondanelli; Email: mariangela.rondanelli@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement; Berberine Phytosome	Dietary supplement: Berberine Phytosome; 2 tablets of 550 mg per day (1 before lunch and 1 before dinner)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Principal Investigator: Mariangela Rondanelli, Fondazione Casemiro Mondino

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): May 28, 2020
• Study Completion (Anticipated): July 25, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: ID 0912/14122018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No