HyperlipidemiaNCT06002893
The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive
A study testing Cholesfytol NG®) supplement in people with Hyperlipidemia, run by Liaquat University of Medical & Health Sciences at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Cholesfytol NG®) supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Mar 2020to 31 Jul 2023
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant nor breastfeeding patients
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven
Leuven
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Cholesfytol NG®) supplement
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholesfytol NG®) supplementDietary supplement
General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement
| Study group | Role | What they receive |
|---|---|---|
| Cholesfytol NG®) supplement | Experimental | Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months. Receives: Dietary Supplement: Cholesfytol NG®) supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood lipid profile
Decrease in blood total cholesterol (TC) concentration
Measured: 2-months
Change in blood lipid profile
Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration
Measured: 2-months
Change in blood lipid profile
Decrease in blood triglycerides (TG) concentration
Measured: 2-months
Change in blood lipid profile
Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
Measured: 2-months
Decrease in blood lipid profile
Change in blood remnant cholesterol (RC) concentration
Measured: 2-months
Secondary outcomes (1)
Rate of side effects
Number of patients reporting myalgia
Measured: 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start19 Mar 2020
- Primary completion31 Mar 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cholesfytol NG®) supplement treatment
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002893
- Sponsor's protocol ID
- AK/08.08.2023/01
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermans MP, Dierckxsens Y, Janssens I, Seidel L, Albert A, Ahn SA, Rousseau MF, Khan A. The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia. Front Pharmacol. 2023 Nov 27;14:1280234. doi: 10.3389/fphar.2023.1280234. eCollection 2023.
PubMed 38089061
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06002893
- Acronym / sponsor ID
- AK/08.08.2023/01
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cholesfytol NG®) supplement treatment
| Arm | Type | Receives |
|---|---|---|
| Cholesfytol NG®) supplement | Experimental | Dietary Supplement: Cholesfytol NG®) supplementPatients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant nor breastfeeding patients
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 NG®) supplementGeneral Practitioner (GP) prescribed oral Cholesfytol NG®) supplement | Dietary supplement | Cholesfytol NG®) supplement |
Primary outcome
Change in blood lipid profile
Time frame: 2-months
Decrease in blood total cholesterol (TC) concentration
Change in blood lipid profile
Time frame: 2-months
Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration
Change in blood lipid profile
Time frame: 2-months
Decrease in blood triglycerides (TG) concentration
Change in blood lipid profile
Time frame: 2-months
Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration
Decrease in blood lipid profile
Time frame: 2-months
Change in blood remnant cholesterol (RC) concentration
1 secondary outcome
Rate of side effects
Time frame: 2-months
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 21 Aug 2023.
- Derived from this study: PubMed 38089061Hermans MP, Dierckxsens Y, Janssens I, Seidel L, Albert A, Ahn SA, Rousseau MF, Khan A. The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia. Front Pharmacol. 2023 Nov 27;14:1280234. doi: 10.3389/fphar.2023.1280234. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholesfytol NG®) supplement in people with Hyperlipidemia, run by Liaquat University of Medical & Health Sciences 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 7 inclusion and 1 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 21 Aug 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 in blood lipid profile (time frame: 2-months). The study lists 5 primary outcomes in all. 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 NCT06002893, which also lists 1 linked publication.
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 21 Aug 2023.