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

Not Applicable

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Cholesfytol NG®) supplement

• Registration Number: NCT06002893
• Lead Sponsor: Liaquat University of Medical & Health Sciences

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.

Study Timeline

• Study Start: 2020-03-19
• Primary Completion: 2022-03-31
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-18
• Last Update Submitted: 2023-08-18
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in blood lipid profile	2-months	Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
Decrease in blood lipid profile	2-months	Change in blood remnant cholesterol (RC) concentration

Secondary Outcome Measures

Name	Time	Method
Rate of side effects	2-months	Number of patients reporting myalgia

Trial Locations

Locations (1)

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