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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Cholesfytol NG®) supplement

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 Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of side effects	Number of patients reporting myalgia	2-months

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: AK/08.08.2023/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No