NCT05031715

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

March 3, 2022

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 27, 2021

Last Update Submit

February 15, 2022

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 weeks and at 8 weeks

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 weeks and at 8 weeks

  • Changes on anthropometry

    Changes from baseline anthropometry at 4 weeks and at 8 weeks

  • Changes on body composition

    Changes from baseline body composition at 4 weeks and at 8 weeks

  • Changes on lipid profile

    Changes from baseline lipid profile at 4 weeks and at 8 weeks

  • +4 more secondary outcomes

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Berberine Phytosome

Dietary Supplement: Berberine Phytosome

Interventions

Berberine PhytosomeDIETARY_SUPPLEMENT

2 tablets of 550 mg per day (1 before lunch and 1 before dinner)

Dietary supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariangela Rondanelli

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mariangela Rondanelli

    Fondazione Casemiro Mondino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariangela Rondanelli

CONTACT

+390382381749mariangela.rondanelli@unipv.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

March 2, 2020

Primary Completion

May 28, 2020

Study Completion

July 25, 2022

Last Updated

March 3, 2022

Record last verified: 2021-08

Locations

IT(1)