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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04793451
Eligibility Criteria:
Inclusion Criteria:
* informed written consent;
* simple obesity;
* age from 18 to 65 years;
* body fat content, assessed by electrical bioimpedance, equal to or more than 33%;
* waist circumference more than 80 cm;
* stable body weight in the one month prior to the trial.
Exclusion Criteria:secondary form of excess body mass
* secondary form of arterial hypertension
* mean systolic blood pressure \> 140 mmHg and/or mean diastolic blood pressure \> 90 mmHg;
* diabetes;
* ischemic heart disease;
* stroke;
* heart failure;
* history of malignancy;
* clinically significant heart arrhythmias;
* a history of use of any dietary supplement;
* serious liver or kidney damage;
* abnormal thyroid gland function;
* clinically significant inflammation, connective tissue disease, or arthritis;
* nicotine, alcohol, or narcotic abuse;
* infection;
* pregnancy, childbirth, or lactation;
* any other condition that would make participation not in the best interest of the subject, or could prevent the efficacy of the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04793451
Study Brief:
Protocol Section:
NCT04793451