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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT06441695
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 35-50 years (both limits inclusive);
* Body mass index (BMI) of 18.50-29.99 kg/m2 -Habitual moderate caffeine consumers (200-400 mg/day) assessed through caffeine assessment tool (Caffeine -
* Consumption Questionnaire, CCQ);
* Intermediate chronotype (\>31 or \<69 on Morningness-Eveningness Questionnaire).
Exclusion Criteria:
* Subjects presenting any of the following will not be included in the study:
* No history of anxiety disorders or sleep disorders;
* Non-smokers;
* Alcohol consumption 72 hours prior to the start of study/consumption of study product;
* No use of sleep medicines, melatonin, marijuana within two weeks of start of study;
* No travel involving time zone change, shift work, or other life events that alter sleep schedule \>3 hours from the norm one week before the start of study (assessed using sleep-wake schedule diary for week prior to study);
* Caffeine restricted past 12 PM from the day prior to the start of study (verify through caffeine diet history).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT06441695
Study Brief:
Protocol Section:
NCT06441695