MedTrace Logo

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+)

NCT07178769 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-09-17

No results posted yet for this study

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.

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:

1. 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.
2. 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.
3. 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

Interventions

DIETARY_SUPPLEMENT

ARKOSTEROL

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).

Sponsors & Collaborators

  • Laboratoires Arkopharma

    lead INDUSTRY

Principal Investigators

  • Guyoux Aurelie · Arkopharma Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178769 on ClinicalTrials.gov