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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002893
• Other study ID #: AK/08.08.2023/01
• Status: Completed
• Phase: N/A
• Start date: March 19, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Cholesfytol NG®) supplement
General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement

Locations

Country	Name	City	State
Belgium	Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood lipid profile	Decrease in blood total cholesterol (TC) concentration	2-months
Primary	Change in blood lipid profile	Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration	2-months
Primary	Change in blood lipid profile	Decrease in blood triglycerides (TG) concentration	2-months
Primary	Change in blood lipid profile	Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration	2-months
Primary	Decrease in blood lipid profile	Change in blood remnant cholesterol (RC) concentration	2-months
Secondary	Rate of side effects	Number of patients reporting myalgia	2-months