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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT05459961
Eligibility Criteria:
Inclusion Criteria:
Caucasian men, 50-70 years of age
Non-user or former users (cessation ≥6 months) of nicotine products (e.g., cigarettes, chewing tobacco) during the study period.
Non-user or former users (cessation ≥6 months) of any marijuana or hemp products and no plans to use marijuana or hemp products during the study period
Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
No health conditions that would prevent the subject from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination, and routine laboratory test results.
Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion Criteria:
Abnormal laboratory test results of clinical significance
Clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product
Type I or Type II diabetes mellitus.
Uncontrolled pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, endocrine, hematologic, immunologic, or neurologic disease.
Had a positive SARS-CoV2 (COVID) test and experienced symptoms for \> 2 months (i.e. long COVID)
Has a condition the Clinical Investigator believes would interfere with ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT05459961
Study Brief:
Protocol Section:
NCT05459961