Berberine and Altered Fasting Glucose

Sponsor
Azienda di Servizi alla Persona di Pavia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05031715
Collaborator
(none)
50
1
1
28.7
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Berberine Phytosome
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 2, 2020
Actual Primary Completion Date :
May 28, 2020
Anticipated Study Completion Date :
Jul 25, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Changes on carbohydrate profile [Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks]

    Fasting Glucose (mg/dl)

  3. Changes on carbohydrate profile [Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks]

    Glycated hemoglobin (%)

Secondary Outcome Measures

  1. Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]

    Weight (Kg)

  2. Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]

    Body Mass Index (Kg/m2)

  3. Changes on anthropometry [Changes from baseline anthropometry at 4 weeks and at 8 weeks]

    Waist circumference (cm)

  4. 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)

  5. 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)

  6. 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]

    Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l)

  7. 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]

    Gamma Glutamyl Transferase (U/l)

  8. 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]

    Creatinine (mg/dl)

  9. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Fasting blood glucose range:100-125 mg/dl
Exclusion Criteria:
  • Diabetes mellitus

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mariangela Rondanelli Pavia Italy 27100

Sponsors and Collaborators

  • Azienda di Servizi alla Persona di Pavia

Investigators

  • Principal Investigator: Mariangela Rondanelli, Fondazione Casemiro Mondino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Azienda di Servizi alla Persona di Pavia
ClinicalTrials.gov Identifier:
NCT05031715
Other Study ID Numbers:
  • ID 0912/14122018
First Posted:
Sep 2, 2021
Last Update Posted:
Mar 3, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022