University of Georgia
Athens, Georgia, 30602, United States
NCT Number: NCT05000190
The primary study objectives are to test whether among a sample of healthy adults consuming: (1) a single capsule containing 250 mg citicoline has an effect on attentional performance 1, 2 and 3 h post-dose compared to placebo (acute effect), and (2) capsule containing 250 mg citicoline per day for 28 consecutive days has an effect on attentional performance compared to placebo (chronic effect).
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Athens, Georgia, 30602, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule daily for 28 days
1 capsule daily for 28 days
Time frame: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Attention performance during the Connors Continuous Performance Test- version III (CPT-III)
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Attention performance during the (CPT)-III
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Attention performance during the CPT-III
Time frame: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Attention performance during the CPT-III
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Attention performance indicator from the CPT-III
Time frame: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Attention performance indicator from the CPT-III
Time frame: Immediately post-dose (baseline Day 1)
Measured by two item questionnaire, 5 selections each item, from very much worse to very much better than expected mental task performance if assigned to active and if assigned to placebo
Time frame: Upon arrival (baseline Day 1)
Questionnaire about number of hours of sleep last night
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose immediately prior to tests of attention
Single question, How do you feel right now, rated on visual analog scale (VAS) from 0 (no motivation at all) to 100 (strongest degree of motivation imaginable)
Time frame: Immediately prior to the test of attention, change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose
6 questions rated by visual analog scale (VAS) from 0 mm (weakest) to 100 mm (strongest) feelings
Time frame: Immediately prior to the test of attention, change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose mood states, immediately prior to tests of attention
Profile of Mood States (POMS) questionnaire, 30 questions, How do you feel right now, rated 0 (not at all) to 4 (extremely)
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose
Beats per minute via wearable heart rate monitor
Time frame: Change from post-dose baseline Day 1 to Day 29 measured by
Two item questionnaire, 5 selections each item, from very much worse to very much better than expected mental task performance if had been assigned to active and if had been assigned to placebo for 28 days
Time frame: Change from number of hours of sleep the night before baseline Day 1 versus the number of hours of sleep the night before Day 29
Questionnaire about number of hours of sleep last night
Time frame: Change from pre-dose baseline Day 1 to Day 29
Single question, How do you feel right now, rated on visual analog scale (VAS) from 0 (no motivation at all) to 100 (strongest degree of motivation imaginable)
Time frame: Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29
6 questions rated by visual analog scale (VAS) from 0 mm (weakest) to 100 mm (strongest) feelings
Time frame: Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29
Profile of Mood States (POMS) questionnaire, , 30 questions, How do you feel right now, rated 0 (not at all) to 4 (extremely)
Time frame: Change from pre-dose baseline Day 1 to Day 29
Beats per minute via wearable heart rate monitor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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