NCT06002893

Brief Summary

Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 19, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

August 8, 2023

Last Update Submit

August 18, 2023

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (5)

  • Change in blood lipid profile

    Decrease in blood total cholesterol (TC) concentration

    2-months

  • Change in blood lipid profile

    Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration

    2-months

  • Change in blood lipid profile

    Decrease in blood triglycerides (TG) concentration

    2-months

  • Change in blood lipid profile

    Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration

    2-months

  • Decrease in blood lipid profile

    Change in blood remnant cholesterol (RC) concentration

    2-months

Secondary Outcomes (1)

  • Rate of side effects

    2-months

Study Arms (1)

Cholesfytol NG®) supplement

EXPERIMENTAL

Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.

Dietary Supplement: Cholesfytol NG®) supplement

Interventions

Cholesfytol NG®) supplementDIETARY_SUPPLEMENT

General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement

Cholesfytol NG®) supplement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 years
  • Both male or female
  • Blood total cholesterol (TC) level ≥ 200 mg/dL
  • Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL
  • With or without myalgia and/or diabetes
  • No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target
  • Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia

You may not qualify if:

  • Pregnant nor breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven

Leuven, Belgium

Location

Related Publications (1)

  • Hermans MP, Dierckxsens Y, Janssens I, Seidel L, Albert A, Ahn SA, Rousseau MF, Khan A. The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia. Front Pharmacol. 2023 Nov 27;14:1280234. doi: 10.3389/fphar.2023.1280234. eCollection 2023.

    PMID: 38089061DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cholesfytol NG®) supplement treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 21, 2023

Study Start

March 19, 2020

Primary Completion

March 31, 2022

Study Completion

July 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)