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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg citicoline | Experimental | Opaque capsule |
|
| 0 mg citicoline | Placebo Comparator | Opaque capsule matched in appearance to the active capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active capsule | Dietary Supplement | 1 capsule daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Errors of commission after 28-day consumption (chronic effect) | Attention performance during the Connors Continuous Performance Test- version III (CPT-III) | Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores |
| Measure | Description | Time Frame |
|---|---|---|
| Errors of commission after acute dosing (single dose on Day 1, the first of 28 daily doses) | Attention performance during the (CPT)-III | Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1) |
| Errors of omission after acute dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J O'Connor, PhD | University of Georgia, Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo capsule |
| Other |
1 capsule daily for 28 days |
|
Attention performance during the CPT-III |
| Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1) |
| Errors of omission after chronic dosing | Attention performance during the CPT-III | Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores |
| Reaction time after acute dosing | Attention performance indicator from the CPT-III | Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1) |
| Reaction time after chronic dosing | Attention performance indicator from the CPT-III | Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores |
| For the acute study only, expectation for change in mental task performance associated with consuming one capsule that may contain citicoline | 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 | Immediately post-dose (baseline Day 1) |
| For acute study only, sleep behavior the night prior to testing | Questionnaire about number of hours of sleep last night | Upon arrival (baseline Day 1) |
| For the acute study only, motivation to complete the attention task | 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) | Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose immediately prior to tests of attention |
| For the acute study only, feelings of mental energy and fatigue | 6 questions rated by visual analog scale (VAS) from 0 mm (weakest) to 100 mm (strongest) feelings | Immediately prior to the test of attention, change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose |
| For the acute study only, mood states (anxiety) | Profile of Mood States (POMS) questionnaire, 30 questions, How do you feel right now, rated 0 (not at all) to 4 (extremely) | 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 |
| For the acute study only, high frequency (HF) and low frequency (LF) domains of heart rate variability, a biomarker of cognitive function, during the tests of attention | Beats per minute via wearable heart rate monitor | Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose |
| For the chronic study only, expectation for change in mental task performance associated with consuming one capsule daily for 28-days that may contain citicoline | 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 | Change from post-dose baseline Day 1 to Day 29 measured by |
| For the chronic study only, sleep behavior the night prior to testing | Questionnaire about number of hours of sleep last night | 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 |
| For the chronic study only, motivation to complete the attention task | 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) | Change from pre-dose baseline Day 1 to Day 29 |
| For the chronic study only, feelings of mental energy and fatigue | 6 questions rated by visual analog scale (VAS) from 0 mm (weakest) to 100 mm (strongest) feelings | Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29 |
| For the chronic study only, mood states (anxiety) questionnaire | Profile of Mood States (POMS) questionnaire, , 30 questions, How do you feel right now, rated 0 (not at all) to 4 (extremely) | Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29 |
| For the chronic study only, high frequency (HF) and low frequency (LF) domains of heart rate variability, a biomarker of cognitive function, during the tests of attention | Beats per minute via wearable heart rate monitor | Change from pre-dose baseline Day 1 to Day 29 |