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

• Sponsor: Liaquat University of Medical & Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT06002893
• Collaborator: KU Leuven (Other)
• Enrollment: 221
• Location: 1
• Arm: 1
• Actual Duration (Months): 40.4
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Dietary Supplement: Cholesfytol NG®) supplement	N/A

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

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Cholesfytol NG®) supplement treatmentCholesfytol 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: Mar 19, 2020
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Change in blood lipid profile [2-months]

   Decrease in blood total cholesterol (TC) concentration

2. Change in blood lipid profile [2-months]

   Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration

3. Change in blood lipid profile [2-months]

   Decrease in blood triglycerides (TG) concentration

4. Change in blood lipid profile [2-months]

   Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration

5. Decrease in blood lipid profile [2-months]

   Change in blood remnant cholesterol (RC) concentration

Secondary Outcome Measures

1. Rate of side effects [2-months]

   Number of patients reporting myalgia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperlipidemias

Study Results

No Results Posted as of Aug 21, 2023