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

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.

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.

Study Overview

• Status: Completed
• Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
• Intervention / Treatment: Dietary supplement: Cholesfytol NG; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • UAntwerp, NatuRAPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cholesfytol NG; 3 capsules daily (orally) with dinner containing in total 1000 mg of Amla dry extract, 100 mg of Walnut leaf dry extract, 67.2 mg of Red yeast rice powder (equivalent to 2.9 mg of monacolines), 50 mg of olive fruit dry extract (equivalent to 10 mg of hydroxytyrosol). Taken for 8 weeks	Dietary supplement: Cholesfytol NG; 3 capsules a day with dinner.
Placebo Comparator: Placebo; 3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc	Other: Placebo; 3 capsules a day with dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline LDL cholesterol at 8 weeks	Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline HDL cholesterol level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks	Measurement with ELISA	Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks	Measurement with ELISA	Baseline, 8 weeks
Frequency of side effects (+ their burden) as reported in the final questionnaire	Unvalidated but standardized questionnaire on typical statin-related side effects	8 weeks
Change from baseline Blood Pressure, Systolic at 8 weeks	average of 3 measurements during 15 minutes	Baseline, 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks	average of 3 measurements during 15 minutes	Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks	Calculated from HDL and total cholesterol	Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks	Calculated from total, HDL and LDL cholesterol	Baseline, 8 weeks
Change from baseline glutathion (GSH) level at 8 weeks	Measurement with in house HPLC method	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline glucose level at 8 weeks	Measurement in Fluoride Plasma	Baseline, 8 weeks
Change from baseline insuline level at 8 weeks	Required to correctly interpret glucose levels, Measurement in Serum	Baseline, 8 weeks
Change from baseline homocysteine level at 8 weeks	Measurement in Homocysteine Serum	Baseline, 8 weeks
Change from baseline hs-CRP level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline creatinine level at 8 weeks	Required to correctly interpret HbAc1 levels, Measurement in Serum	Baseline, 8 weeks
Change from baseline HbA1c level at 8 weeks	Measurement in EDTA Whole Blood	Baseline, 8 weeks
Change from baseline hemoglobine level at 8 weeks	Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood	Baseline, 8 weeks
Change from baseline waist circumference at 8 weeks	Measurement with measuring tape	Baseline, 8 weeks
Change from baseline Body Mass Index (BMI) at 8 weeks	Weight and height will be combined to report BMI in kg/m^2	Baseline, 8 weeks
Change from baseline creatine kinase (CK) level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Change from baseline C-peptide level at 8 weeks	Measurement in Serum	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Nina Hermans
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: Johan Bosmans, Prof. MD., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: AmWaRO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No