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OpenTrials
Completed

NCT Number: NCT06002893

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholesfytol NG®) supplement

Dietary Supplement

General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement

Primary outcomes

  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 outcomes

  1. Rate of side effects

    Time frame: 2-months

    Number of patients reporting myalgia

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • KU Leuven

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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