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The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cholesfytol NG®) supplement
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Pregnant nor breastfeeding patients

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cholesfytol NG®) supplement

Arm Description

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

Outcomes

Primary Outcome Measures

Change in blood lipid profile
Decrease in blood total cholesterol (TC) concentration
Change in blood lipid profile
Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration
Change in blood lipid profile
Decrease in blood triglycerides (TG) concentration
Change in blood lipid profile
Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
Decrease in blood lipid profile
Change in blood remnant cholesterol (RC) concentration

Secondary Outcome Measures

Rate of side effects
Number of patients reporting myalgia

Full Information

First Posted
August 8, 2023
Last Updated
August 18, 2023
Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT06002893
Brief Title
The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive
Official Title
The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cholesfytol NG®) supplement treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholesfytol NG®) supplement
Arm Type
Experimental
Arm Description
Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholesfytol NG®) supplement
Intervention Description
General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement
Primary Outcome Measure Information:
Title
Change in blood lipid profile
Description
Decrease in blood total cholesterol (TC) concentration
Time Frame
2-months
Title
Change in blood lipid profile
Description
Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration
Time Frame
2-months
Title
Change in blood lipid profile
Description
Decrease in blood triglycerides (TG) concentration
Time Frame
2-months
Title
Change in blood lipid profile
Description
Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
Time Frame
2-months
Title
Decrease in blood lipid profile
Description
Change in blood remnant cholesterol (RC) concentration
Time Frame
2-months
Secondary Outcome Measure Information:
Title
Rate of side effects
Description
Number of patients reporting myalgia
Time Frame
2-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant nor breastfeeding patients
Facility Information:
Facility Name
Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive

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