NCT05031715UnknownNot Applicable
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
Azienda di Servizi alla Persona di Pavia2 sites in 1 country50 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Changes on insulin resistance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Fasting blood glucose range:100-125 mg/dl
Exclusion Criteria
- •Diabetes mellitus
Outcomes
Primary Outcomes
Changes on insulin resistance
Time Frame: Changes from baseline insulin resistance at 4 weeks and at 8 weeks
Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2,4
Changes on carbohydrate profile
Time Frame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Fasting Glucose (mg/dl)
Secondary Outcomes
- 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)
- Changes on anthropometry(Changes from baseline anthropometry at 4 weeks and at 8 weeks)
- 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)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiCholDyslipidemiasNCT06340308University of Pavia36
Completed
Not Applicable
Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot StudyMetabolic SyndromeNCT03976336University of Kansas Medical Center15
Completed
Not Applicable
Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish WomenDietary SupplementsQuality of LifeMenopauseNCT04381026Nektium Pharma SL57
Completed
Not Applicable
The Absorption of Bioactive Berberine in HumanHealthyNCT03438292University of Florida32
Completed
Phase 4
Nutraceutical on HyperuricemiaHyperuricemiaNCT04161872University of Pavia116