Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT02548832
Eligibility Criteria:
Inclusion Criteria:
A. Men and women
B. Accomplished age 30 to 60 years
C. Diagnosis of mixed dyslipidemia established to meet the following criteria:
* Total cholesterol \> 5,17 mmol/l.
* Triglycerides \> 1,7 mmol/l.
D. BMI of 25 kg / m\^2 to 39.9 kg / m\^2, weight stable over the past three months, defined as a variability in the lower body weight of 5%.
E. No drug treatment for lipid profile 3 months prior to baseline.
F. Women must ensure a non-hormonal method to avoid pregnancy during the study period.
G. Written information consent
Exclusion Criteria:
A. Removal for informed consent letter
B. Loss of monitoring
C. Presence of serious adverse event
D. Adherence to treatment \<80%
E. Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and body weight during the intervention period influence
F. Intolerance or not tolerability or hypersensitivity to the compounds used in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT02548832
Study Brief:
Protocol Section:
NCT02548832