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Completed

NCT Number: NCT06333158

Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention

The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia

1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL, 2. Leads to a clinically relevant reduction of blood pressure on the short term, 3. Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:

* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day * Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UAntwerp, NatuRAPT

Wilrijk, Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • LDL ≥ 130 mg/dL

Exclusion criteria

  • <18 jaar
  • >76 jaar
  • Smoking
  • Use of nutritional supplements or (chronic) medication*
  • Triglycerides > 400 mg/dL
  • > 14 alcoholic consumptions/week
  • Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
  • Acute infection
  • Current pregnancy or pregnancy wish during the study period
  • Breast feeding
  • When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication. Use of lipid lowering medication of food supplements is only permitted after a wash out period of at least 6 weeks.

Treatment and study plan

Cholesfytol NG

Dietary Supplement

3 capsules a day with dinner.

Placebo

Other

3 capsules a day with dinner

Primary outcomes

  1. Change from baseline LDL cholesterol at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides

Secondary outcomes

  1. Frequency of side effects (+ their burden) as reported in the final questionnaire

    Time frame: 8 weeks

    Unvalidated but standardized questionnaire on typical statin-related side effects

  2. Change from baseline Blood Pressure, Systolic at 8 weeks

    Time frame: Baseline, 8 weeks

    average of 3 measurements during 15 minutes

  3. Change from baseline Blood Pressure, diastolic at 8 weeks

    Time frame: Baseline, 8 weeks

    average of 3 measurements during 15 minutes

  4. Change from baseline total cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  5. Change from baseline HDL cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  6. Change from baseline non-HDL cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from HDL and total cholesterol

  7. Change from baseline Remnant Cholesterol at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from total, HDL and LDL cholesterol

  8. Change from baseline triglycerides level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  9. Change from baseline Apo A1 level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  10. Change from baseline Apo B level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  11. Change from baseline lipoprotein A (LP(a)) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  12. Change from baseline OxLDL level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with ELISA

  13. Change from baseline malondialdehyde (MDA) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with ELISA

  14. Change from baseline glutathion (GSH) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with in house HPLC method

Other outcomes

  1. Change from baseline glucose level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Fluoride Plasma

  2. Change from baseline HbA1c level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in EDTA Whole Blood

  3. Change from baseline insuline level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret glucose levels, Measurement in Serum

  4. Change from baseline Body Mass Index (BMI) at 8 weeks

    Time frame: Baseline, 8 weeks

    Weight and height will be combined to report BMI in kg/m^2

  5. Change from baseline waist circumference at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with measuring tape

  6. Change from baseline hemoglobine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood

  7. Change from baseline creatinine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret HbAc1 levels, Measurement in Serum

  8. Change from baseline hs-CRP level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  9. Change from baseline homocysteine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Homocysteine Serum

  10. Change from baseline creatine kinase (CK) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  11. Change from baseline C-peptide level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

Sponsors and collaborators

Lead sponsor

Nina Hermans

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Combination Preparation (Cholesfytol NG®) As Compared to Placebo in Patients with Hypercholesterolemia: a RDBPC Trial.

Acronym: AmWaRO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Nov 14, 2024

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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