Back to resultsBerberine and Altered Fasting Glucose
Primary Purpose
Glucose Metabolism Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Berberine Phytosome
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Metabolism Disorders
Eligibility Criteria
Inclusion Criteria:
- Fasting blood glucose range:100-125 mg/dl
Exclusion Criteria:
- Diabetes mellitus
Sites / Locations
- Mariangela RondanelliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary supplement
Arm Description
Berberine Phytosome
Outcomes
Primary Outcome Measures
Changes on insulin resistance
Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2,4
Changes on carbohydrate profile
Fasting Glucose (mg/dl)
Changes on carbohydrate profile
Glycated hemoglobin (%)
Secondary Outcome Measures
Changes on anthropometry
Weight (Kg)
Changes on anthropometry
Body Mass Index (Kg/m2)
Changes on anthropometry
Waist circumference (cm)
Changes on body composition
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
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 on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l)
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Gamma Glutamyl Transferase (U/l)
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Creatinine (mg/dl)
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Glomerural Filtrate Rate (ml/min)
Full Information
NCT ID
NCT05031715
First Posted
August 27, 2021
Last Updated
February 15, 2022
Sponsor
Azienda di Servizi alla Persona di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05031715
Brief Title
Berberine and Altered Fasting Glucose
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
July 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary supplement
Arm Type
Experimental
Arm Description
Berberine Phytosome
Intervention Type
Dietary Supplement
Intervention Name(s)
Berberine Phytosome
Intervention Description
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
Primary Outcome Measure Information:
Title
Changes on insulin resistance
Description
Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2,4
Time Frame
Changes from baseline insulin resistance at 4 weeks and at 8 weeks
Title
Changes on carbohydrate profile
Description
Fasting Glucose (mg/dl)
Time Frame
Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Title
Changes on carbohydrate profile
Description
Glycated hemoglobin (%)
Time Frame
Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Secondary Outcome Measure Information:
Title
Changes on anthropometry
Description
Weight (Kg)
Time Frame
Changes from baseline anthropometry at 4 weeks and at 8 weeks
Title
Changes on anthropometry
Description
Body Mass Index (Kg/m2)
Time Frame
Changes from baseline anthropometry at 4 weeks and at 8 weeks
Title
Changes on anthropometry
Description
Waist circumference (cm)
Time Frame
Changes from baseline anthropometry at 4 weeks and at 8 weeks
Title
Changes on body composition
Description
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Time Frame
Changes from baseline body composition at 4 weeks and at 8 weeks
Title
Changes on lipid profile
Description
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)
Time Frame
Changes from baseline lipid profile at 4 weeks and at 8 weeks
Title
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l)
Time Frame
Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Title
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Gamma Glutamyl Transferase (U/l)
Time Frame
Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Title
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Creatinine (mg/dl)
Time Frame
Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Title
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Glomerural Filtrate Rate (ml/min)
Time Frame
Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fasting blood glucose range:100-125 mg/dl
Exclusion Criteria:
Diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariangela Rondanelli
Phone
+390382381749
Email
mariangela.rondanelli@unipv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Organizational Affiliation
Fondazione Casemiro Mondino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariangela Rondanelli
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Phone
0382381749
Email
mariangela.rondanelli@unipv.it
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Email
mariangela.rondanelli@unipv.it
12. IPD Sharing Statement
Learn more about this trial
Berberine and Altered Fasting Glucose
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