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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06002893

Enrollment

221

Registered

2023-08-21

Start date

2020-03-19

Completion date

2023-07-31

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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.

Interventions

DIETARY_SUPPLEMENTCholesfytol NG®) supplement

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Cholesfytol NG®) supplement treatment

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in blood lipid profile	2-months	Decrease in blood total cholesterol (TC) concentration
Decrease in blood lipid profile	2-months	Change in blood remnant cholesterol (RC) concentration

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026