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

November 12, 2024 updated by: Nina Hermans

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline LDL cholesterol at 8 weeks
Time Frame: Baseline, 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline HDL cholesterol level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement with ELISA
Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement with ELISA
Baseline, 8 weeks
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
8 weeks
Change from baseline Blood Pressure, Systolic at 8 weeks
Time Frame: Baseline, 8 weeks
average of 3 measurements during 15 minutes
Baseline, 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks
Time Frame: Baseline, 8 weeks
average of 3 measurements during 15 minutes
Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks
Time Frame: Baseline, 8 weeks
Calculated from HDL and total cholesterol
Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks
Time Frame: Baseline, 8 weeks
Calculated from total, HDL and LDL cholesterol
Baseline, 8 weeks
Change from baseline glutathion (GSH) level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement with in house HPLC method
Baseline, 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline glucose level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Fluoride Plasma
Baseline, 8 weeks
Change from baseline insuline level at 8 weeks
Time Frame: Baseline, 8 weeks
Required to correctly interpret glucose levels, Measurement in Serum
Baseline, 8 weeks
Change from baseline homocysteine level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Homocysteine Serum
Baseline, 8 weeks
Change from baseline hs-CRP level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline creatinine level at 8 weeks
Time Frame: Baseline, 8 weeks
Required to correctly interpret HbAc1 levels, Measurement in Serum
Baseline, 8 weeks
Change from baseline HbA1c level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in EDTA Whole Blood
Baseline, 8 weeks
Change from baseline hemoglobine level at 8 weeks
Time Frame: Baseline, 8 weeks
Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood
Baseline, 8 weeks
Change from baseline waist circumference at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement with measuring tape
Baseline, 8 weeks
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
Baseline, 8 weeks
Change from baseline creatine kinase (CK) level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks
Change from baseline C-peptide level at 8 weeks
Time Frame: Baseline, 8 weeks
Measurement in Serum
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nina Hermans

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Antwerp

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johan Bosmans, Prof. MD., University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings