NCT06340308

Brief Summary

To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 23, 2024

Last Update Submit

March 25, 2024

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Variations of lipid profile

    12 weeks

Study Arms (2)

1 tablet

EXPERIMENTAL
Dietary Supplement: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

2 tablets

ACTIVE COMPARATOR
Dietary Supplement: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

Interventions

Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiCholDIETARY_SUPPLEMENT

Patients will take 1 tablet of Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol for 12 weeks

1 tablet

Eligibility Criteria

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

You may qualify if:

  • LDL Cholesterol \> 115 mg/dl and \< 190 mg/dl
  • primary prevention

You may not qualify if:

  • patients with neoplastic and liver diseases, renal failure and diabetes mellitus
  • pregnant or breastfeeding women
  • hypersensitivity to any of the ingredients
  • therapy with lipid-lowering drugs

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

Interventions

Phytosterolsfenugreek seed meal

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Central Study Contacts

Giuseppe Derosa

CONTACT

+390382502614giuseppe.derosa@unipv.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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 1, 2024

Study Start

June 7, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)