NCT06348550

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 23, 2024

Last Update Submit

March 31, 2024

Conditions

DyslipidemiasDysglycemia

Outcome Measures

Primary Outcomes (1)

  • Variation of LDL cholesterol

    Reduction of LDL-cholesterol after the nutraceutical or placebo intake

    12 months

Secondary Outcomes (2)

  • Variation of lipid profile

    12 months

  • Change in glycemic status

    12 months

Study Arms (2)

Active treatment

ACTIVE COMPARATOR
Dietary Supplement: Berberol® K

Placebo treatment

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Berberol® KDIETARY_SUPPLEMENT

Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®

Active treatment
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S. Matteo Foundation

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Giuseppe Derosa

CONTACT

+390382502614giuseppe.derosa@unipv.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2024

First Posted

April 4, 2024

Study Start

November 30, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

April 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)