Effect of the Association of Berberine Fitosoma® and Mona... | NCT06348550

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2023Actual

Primary Completion Date

Jul 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Mar 23, 2024

First Submission Date that Met QC Criteria

Mar 31, 2024

First Posted Date

Apr 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2024

Last Update Posted Date

Apr 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Derosa, Principal Investigator, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

University of PaviaOTHER

Collaborators

Name	Class
Fondazione IRCCS Policlinico San Matteo di Pavia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Active Comparator		Dietary Supplement: Berberol® K
Placebo treatment	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Berberol® K	Dietary Supplement	Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®	Active treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variation of LDL cholesterol	Reduction of LDL-cholesterol after the nutraceutical or placebo intake	12 months

Secondary Outcomes

Measure	Description	Time Frame
Variation of lipid profile	Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake	12 months
Change in glycemic status	To evaluate the number of subjects changing from impaired fasting glucose or impaired glucose tolerance to type 2 diabetes mellitus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Overweight or obese subjects [according to body mass index (BMI)]
Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)
Total cholesterol values ≥ 200 mg/dl

Exclusion Criteria:

Patients with neoplastic and liver diseases, renal failure
Patients with type 1 or 2 diabetes mellitus
Pregnant or breastfeeding women
Hypersensitivity to any of the ingredients
Therapy with lipid-lowering drugs
Use of products containing red yeast rice

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe Derosa	Contact	+390382502614		giuseppe.derosa@unipv.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico S. Matteo Foundation	Recruiting	Pavia		27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases