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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06002893
Recruitment Status : Completed
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: Cholesfytol NG®) supplement Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cholesfytol NG®) supplement treatment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2020
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : July 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cholesfytol NG®) supplement
Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.
 Dietary Supplement: Cholesfytol NG®) supplement
General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement


Outcome Measures
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Primary Outcome Measures :
  1. Change in blood lipid profile [ Time Frame: 2-months ]
    Decrease in blood total cholesterol (TC) concentration

  2. Change in blood lipid profile [ Time Frame: 2-months ]
    Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration

  3. Change in blood lipid profile [ Time Frame: 2-months ]
    Decrease in blood triglycerides (TG) concentration

  4. Change in blood lipid profile [ Time Frame: 2-months ]
    Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration

  5. Decrease in blood lipid profile [ Time Frame: 2-months ]
    Change in blood remnant cholesterol (RC) concentration


Secondary Outcome Measures :
  1. Rate of side effects [ Time Frame: 2-months ]
    Number of patients reporting myalgia


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002893


Locations
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Belgium
Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven
Leuven, Belgium
Sponsors and Collaborators
Liaquat University of Medical & Health Sciences
KU Leuven
More Information
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Responsible Party: Dr. Amjad Khan, Professor of Clinical Biochemistry and Experimental Medicine, Liaquat University of Medical & Health Sciences
ClinicalTrials.gov Identifier: NCT06002893    
Other Study ID Numbers: AK/08.08.2023/01
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases