CholesterolemiaMETACHOL+NCT07178769
Study To Evaluate The Efficacy And Safety Of A Nutritional Supplement Based On Bergamot, Artichoke And Other Ingredients For Reducing Cholesterol Levels In Patients With Hypercholesterolemia (Metachol+)
A study testing ARKOSTEROL in people with Cholesterolemia, run by Laboratoires Arkopharma at 7 sites in Spain.
Trial summary
The goal of this clinical trial with food supplement is to evaluate the effectiveness of a nutritional supplement based on bergamot, artichoke and other ingredients through low-density lipoprotein (LDL) values after four months of treatment compared to maintaining healthy lifestyle habits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholesterolemia
- What is being tested?
- ARKOSTEROL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 7 sitesSpain
- Study dates
- 20 Apr 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are willing and able to understand and sign the informed consent after the nature of the study has been fully explained to them and they have passed the inclusion/exclusion criteria.
- Patients aged greater than or equal to 18 years
- Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.
Who cannot join
- Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.
- Allergy or hypersensitivity to any of the components of the study treatment.
- Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.
- Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.
- HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
- Liver, kidney or muscle disorders.
- Psychiatric disorders or inability to sign the consent.
- Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Centro de Salud Casco Antiguo
Cartagena, Murcia, 30201
Ana Cebrián Cuenca, PhD, +34686347110, anicebrian@gmail.com
Ana Cebrián Cuenca, PhD
- Recruiting
Centro de Salud Isaac Peral
Cartagena, Murcia, 30300
Maria Jose Delgado, PhD, 686454936, mariadelaunde@gmail.com
Maria Jose Delgado, PhD
- Not yet recruiting
Centro de Salud Goya
Madrid, Madrid, 28009
Gema Montemayor Galán, PhD, +34646525456, montemayorgemma@hotmail.com
Gema Montemayor Galán, PhD
- Recruiting
Centro de Salud Daroca
Madrid, Madrid, 28017
Rocio Arriaza, PhD, +34635564105, rociarri@gmail.com
Javier Santa Cruz Hernández, PhD
- Not yet recruiting
Centro de Salud Avenida de Aragón
Madrid, Madrid, 28027
Ana Javierre Miranda, PhD, 629354864, ajavierre@iies.es
Ana Javierre Miranda, PhD
- Not yet recruiting
Centro de Salud Avenida de Aragón
Madrid, Madrid, 28027
Pilar Puebla Sanz, PhD, +34629905689, pilar.puebla@salud.madrid.org
Pilar Puebla Sanz, PhD
- Recruiting
Centro de Salud de Mazarrón
Mazarrón, Murcia, 30870
Sara Carrasco Claros, PhD, +34968592388, saracarrascoclaros@gmail.com
Sara Carrasco Claros, PhD
About this study
Official title: Multicenter Randomized Open-label Controlled Clinical Study to Evaluate the Efficacy and Safety of a Nutritional Supplement Based on Bergamot, Artichoke and Other Ingredients After Four Months of Treatment in Reducing Cholesterol Levels in Patients With Moderate or Mild Hypercholesterolemia
The goal of this clinical trial with food supplement is to evaluate the effectiveness of a nutritional supplement based on bergamot, artichoke and other ingredients through low-density lipoprotein (LDL) values after four months of treatment compared to maintaining healthy lifestyle habits.
The secondary objectives are
Read more
- Evaluate the improvement of the lipid profile compared to maintaining healthy lifestyle habits.
- Evaluate the difference in effect between 1 tablet and 2 tablets daily in improving the lipid profile.
- Evaluate changes in anthropometric data and vital signs.
- Evaluate adherence to treatment
- Evaluate the safety profile of the product
- Evaluate satisfaction with treatment
There are three treatment arms:
- Arm 1 (Gr 1): Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months.
- Arm 2 (Gr 2): Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months.
- Arm 3 (Control): Patients not taking METACHOL+. All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice.
It is expected to recruit 207 patients in total, 69 in each group/arm
- Conditions
- Cholesterolemia
- Being tested
- ARKOSTEROL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARKOSTEROLDietary supplement
After 2 and 4 months from the start of treatment, a follow-up will be carried out in which anthropometric data will be measured (weight, BMI, waist circumference), vital signs (blood pressure and pulse) and a sample will be taken for analysis to measure the following parameters: CT, LDL, HDL, triglycerides, VLDL, Apo A, Apo B, liver function (GOT, GPT) and kidney function (creatinine) and Liposcale ® (in case of treatment group).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Gr 1) | Experimental | Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months. Receives: Dietary Supplement: ARKOSTEROL |
| Arm 2 (Gr 2) | Experimental | Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months. Receives: Dietary Supplement: ARKOSTEROL |
| Arm 3 (Control): Patients not taking METACHOL+ | No intervention | All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated with a nutritional supplement (regardless of its dose) and patients in the control group.
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group.
Measured: four months
Difference in the change in LDL cholesterol after fou months of treatment compared to the baseline visit between patients treated in 1, 2 and control group
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group
Measured: four months
Secondary outcomes (5)
change in triglycerides
Difference in the change in triglycerides after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2.
Measured: 2-4 months
change in VLDL
Difference in the change in VLDL after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2
Measured: 2-4 months
change in Apo A
Difference in the change in Apo A after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2.
Measured: 2-4 months
change in Apo B
Difference in the change in Apo B after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2
Measured: 2-4 months
change in Liposcale
Difference in the change in Liposcale after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Apr 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Arkopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guyoux Aurelie, Study director, Arkopharma Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178769
- Sponsor's protocol ID
- METACHOL+
- Other IDs
- METACHOL+
- Acronym
- METACHOL+
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Open-label Controlled Clinical Study to Evaluate the Efficacy and Safety of a Nutritional Supplement Based on Bergamot, Artichoke and Other Ingredients After Four Months of Treatment in Reducing Cholesterol Levels in Patients With Moderate or Mild Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07178769
- Acronym / sponsor ID
- METACHOL+ / METACHOL+
- Conditions
- Cholesterolemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Laboratoires ArkopharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
The goal of this clinical trial with food supplement is to evaluate the effectiveness of a nutritional supplement based on bergamot, artichoke and other ingredients through low-density lipoprotein (LDL) values after four months of treatment compared to maintaining healthy lifestyle habits.
The secondary objectives are
- Evaluate the improvement of the lipid profile compared to maintaining healthy lifestyle habits.
- Evaluate the difference in effect between 1 tablet and 2 tablets daily in improving the lipid profile.
- Evaluate changes in anthropometric data and vital signs.
- Evaluate adherence to treatment
- Evaluate the safety profile of the product
- Evaluate satisfaction with treatment
There are three treatment arms:
- Arm 1 (Gr 1): Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months.
- Arm 2 (Gr 2): Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months.
- Arm 3 (Control): Patients not taking METACHOL+. All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice.
It is expected to recruit 207 patients in total, 69 in each group/arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Gr 1) | Experimental | Dietary Supplement: ARKOSTEROLPatients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months. |
| Arm 2 (Gr 2) | Experimental | Dietary Supplement: ARKOSTEROLPatients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months. |
| Arm 3 (Control): Patients not taking METACHOL+ | No intervention | –All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are willing and able to understand and sign the informed consent after the nature of the study has been fully explained to them and they have passed the inclusion/exclusion criteria.
- Patients aged greater than or equal to 18 years
- Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.
Key exclusion criteria (8 listed)
- Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.
- Allergy or hypersensitivity to any of the components of the study treatment.
- Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.
- Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.
- HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
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 |
|---|---|---|
| ARKOSTEROLAfter 2 and 4 months from the start of treatment, a follow-up will be carried out in which anthropometric data will be measured (weight, BMI, waist circumference), vital signs (blood pressure and pulse) and a sample will be taken for analysis to measure the following parameters: CT, LDL, HDL, triglycerides, VLDL, Apo A, Apo B, liver function (GOT, GPT) and kidney function (creatinine) and Liposcale ® (in case of treatment group). | Dietary supplement | Arm 1 (Gr 1), Arm 2 (Gr 2) |
Primary outcome
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated
Time frame: four months
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated with a nutritional supplement (regardless of its dose) and patients in the control group. Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group.
Difference in the change in LDL cholesterol after fou months of treatment compared to the baseline visit between patients treated in 1, 2 and control group
Time frame: four months
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group
5 secondary outcomes
change in triglycerides
Time frame: 2-4 months
change in VLDL
Time frame: 2-4 months
change in Apo A
Time frame: 2-4 months
change in Apo B
Time frame: 2-4 months
change in Liposcale
Time frame: 2-4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- 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.
Guyoux Aurelie study director
Arkopharma Laboratories
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARKOSTEROL in people with Cholesterolemia, run by Laboratoires Arkopharma at 7 sites in Spain.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucía San Miguel Amelivia, Pharmacist (+34 616960711, Lucia.SanMiguel@arkopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated (time frame: four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.