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 @ 1:31 PM
Ignite Modification Date:
2025-12-24 @ 1:31 PM
NCT ID:
NCT05621395
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males aged ≥30 to ≤60 years.
2. Body mass index (BMI) ≥18 and ≤29.9 kg/m2
3. VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg.
4. FAS total score ≥22.
5. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg.
6. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
7. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
8. Individuals who are literate enough to understand the purpose of the study and their rights.
9. Individuals who can give written informed consent and are willing to participate in the study.
Exclusion Criteria:
1. Individuals with a history of any pulmonary disorder.
2. Known cases of hypertension and diabetes mellitus.
3. SpO2 \< 96%
4. Random blood glucose (RBG) levels ≥140 mg/dl.
5. Hemoglobin (Hb) \<13.0 g/dl.
6. Abnormal thyroid stimulating hormone (TSH) value (\<0.4μIU/ml or \>4.2μIU/ml).
7. Individuals with a history of COVID-19 in the last 3 months.
8. Individuals currently on/or having a history of taking blood lipid-lowering medications.
9. Individuals who are unable to run due to any joint disorder.
10. History of smoking or active smokers using any form of tobacco.
11. Individuals with substance abuse problems (within two years) defined as:
* Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
* High-risk drinking as defined as consuming 5 or more alcohol-containing drinks on any day or 15 or more alcohol-containing drinks per week.
12. Individuals who are currently on dietary supplements.
13. Individuals who are currently on diuretics.
14. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
15. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
16. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints.
17. Participation in other clinical trials in the last 90 days before screening.
18. Any condition that could, in the opinion of the Investigator, preclude the participants ability to successfully and safely complete the study or may confound study outcomes.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT05621395
Study Brief:
Protocol Section:
NCT05621395