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:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02110602
Eligibility Criteria:
Inclusion Criteria:
* Adult males
* Ages 20-40
* Healthy
Exclusion Criteria:
* Age less than 20 or greater than 40
* Female sex
* Use of medications and herbal or vitamin supplements during the study or less than one month prior to enrollment in the study
* Body mass index (BMI) less than 20 or greater than 25
* Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
* Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study or plans for changes in exercise level during the study
* Known diabetes or pre-diabetes (based on prior diagnoses; use of medications to lower glucose; or fasting blood glucose \> 100mg/dL at screening)
* Untreated hypertension (defined as systolic blood pressure \> 140mmHg and diastolic blood pressure \> 90mmHg)
* Use of nicotine-containing products, including those inhaled, chewed, or patches during the study.
* Use of drugs of abuse.
* Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric surgery
* Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation to 1 caffeinated beverage per day
* Known anemia (men, hematocrit \< 38%) based on prior testing
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT02110602
Study Brief:
Protocol Section:
NCT02110602