Low-Density-Lipoprotein-Type [LDL] HyperlipoproteinemiaPhase 4AmWaRONCT06333158

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

A Phase 4 study testing Cholesfytol NG in people with Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, run by Nina Hermans at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 76 years
Conditions the study is for: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
What is being tested?: Cholesfytol NG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteBelgium
Study dates: 22 Mar 2024to 13 Jun 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 76 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

LDL ≥ 130 mg/dL

Who cannot join

<18 jaar
>76 jaar
Smoking
Use of nutritional supplements or (chronic) medication*
Triglycerides > 400 mg/dL
> 14 alcoholic consumptions/week

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UAntwerp, NatuRAPT
Wilrijk, Antwerp, 2610

Other trials in Belgium

About this study

Official 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.

Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
Leads to a clinically relevant reduction of blood pressure on the short term,
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.

Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Being tested: Cholesfytol NG, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cholesfytol NGDietary supplement
3 capsules a day with dinner.
PlaceboOther
3 capsules a day with dinner

Study groups in NCT06333158
Study group	Role	What they receive
Cholesfytol NG	Experimental	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 Receives: Dietary Supplement: Cholesfytol NG
Placebo	Placebo comparator	3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline LDL cholesterol at 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Measured: Baseline, 8 weeks

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202413 Jun 2024

First posted27 Mar 2024
Study start22 Mar 2024
Primary completion13 Jun 2024
Study completion13 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low-Density-Lipoprotein-Type [LDL] HyperlipoproteinemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06333158
Sponsor's protocol ID: AmWaRO Study
Acronym: AmWaRO
Status last verified: Mar 2024
First submitted: 20 Mar 2024
Last updated: 14 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT06333158
Acronym / sponsor ID: AmWaRO / AmWaRO Study
Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Nina HermansUniversity, hospital or other
Collaborators: University Hospital, Antwerp
Study start: 22 Mar 2024 (actual)
Primary completion: 13 Jun 2024 (actual)
Study completion: 13 Jun 2024 (actual)
First posted: 27 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
Leads to a clinically relevant reduction of blood pressure on the short term,
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cholesfytol NG	Experimental	Dietary Supplement: Cholesfytol NG3 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
Placebo	Placebo comparator	Other: Placebo3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc

Who may qualify

Ages: 18 to 76 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

LDL ≥ 130 mg/dL

Key exclusion criteria (11 listed)

<18 jaar
>76 jaar
Smoking
Use of nutritional supplements or (chronic) medication*
Triglycerides > 400 mg/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cholesfytol NG3 capsules a day with dinner.	Dietary supplement	Cholesfytol NG
Placebo3 capsules a day with dinner	Other	Placebo

Primary outcome

Change from baseline LDL cholesterol at 8 weeks
Time frame: Baseline, 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides

14 secondary outcomes

Frequency of side effects (+ their burden) as reported in the final questionnaire
Time frame: 8 weeks
Change from baseline Blood Pressure, Systolic at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline HDL cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline glutathion (GSH) level at 8 weeks
Time frame: Baseline, 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johan Bosmans, Prof. MD. principal investigator

University Hospital, Antwerp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cholesfytol NG in people with Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, run by Nina Hermans at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline LDL cholesterol at 8 weeks (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.