AttentionNCT05000190
Acute and Chronic Effect of 250 mg Citicoline Consumption on Attention in Adults: A Randomized Trial
A study testing Active capsule in people with Attention, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention
- What is being tested?
- Active capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant, non-lactating females, 18-60 years of age
- Self-report of good health
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- Willing to maintain current dietary supplement use (e.g., multi-vitamin or other supplements approved by investigator, stimulants excluded) throughout the 28 days of the trial. On test days, participant agrees not to take any of their usual dietary supplements until dismissal from University of Georgia.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Who cannot join
- Failure to meet any one of the inclusion criteria
- Potential participant will be excluded if the individual is being paid to do work by Dr. O'Connor, is unwilling to comply with safety instructions (e.g., to wear a face covering) or reports:
- Vision problems that cannot be corrected with glasses or contact lenses
- usual daily consumption of ≥ 500 mg caffeine
- Consumption of caffeine or other stimulants, such as stimulant medication commonly used for ADHD (e.g. Ritalin or Adderall), within 12 h of testing. Prescription medications are allowed as long as they do not interfere with testing.
- Major trauma or major surgical event within 6 months of screening
Show all 21Show fewer
- Known intolerance, sensitivity or allergy to any ingredients in the study products
- Extreme dietary habits, as judged by the Investigator
- Moderate or higher intensity exercise of 15 or more minutes completed fewer than 3-h prior to a laboratory testing session.
- Consumption of food or caloric drinks fewer than 2-h prior to the laboratory testing session.
- Consumption of supplements, vitamins and multi-vitamins prior to testing on testing days. Participants can take dietary supplements that they have agreed to maintain on testing days after completing the testing visit.
- Any history of a diagnosed psychiatric or neurobehavioral (e.g., ADHD) disorder
- A history of frequent gastrointestinal distress in response to meals or medicine
- History of cancer in the prior two years, except for non-melanoma skin cancer
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Exposure to citicoline within 30 d prior to screening
- Participant has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- Increased risk of exposure to COVID-19
- Increased risk of a severe reaction to exposure to COVID-19
- Participation in a PepsiCo study at the University of Georgia for at least 6 months from signing the consent form
- Participation in any clinical trial for at least 30 days from signing the consent form
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Attention
- Being tested
- Active capsule, Placebo capsule
- Keywords
- cognition, attention, attentional performance, CPT-III, citicoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active capsuleDietary supplement
1 capsule daily for 28 days
Placebo capsuleOther
1 capsule daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 250 mg citicoline | Experimental | Opaque capsule Receives: Dietary Supplement: Active capsule |
| 0 mg citicoline | Placebo comparator | Opaque capsule matched in appearance to the active capsule Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Errors of commission after 28-day consumption (chronic effect)
Attention performance during the Connors Continuous Performance Test- version III (CPT-III)
Measured: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Secondary outcomes (17)
Errors of commission after acute dosing (single dose on Day 1, the first of 28 daily doses)
Attention performance during the (CPT)-III
Measured: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Errors of omission after acute dosing
Attention performance during the CPT-III
Measured: 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
Measured: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Reaction time after acute dosing
Attention performance indicator from the CPT-III
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: Change from pre-dose baseline Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start13 Sep 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, PhD, Principal investigator, University of Georgia, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000190
- Sponsor's protocol ID
- PEP-2101
- Status last verified
- Nov 2022
- First submitted
- 3 Aug 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effect of 250 mg Citicoline Consumption on Attention in Adults: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05000190
- Acronym / sponsor ID
- PEP-2101
- Conditions
- Attention
- Keywords
- cognition, attention, attentional performance, CPT-III, citicoline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 250 mg citicoline | Experimental | Dietary Supplement: Active capsuleOpaque capsule |
| 0 mg citicoline | Placebo comparator | Other: Placebo capsuleOpaque capsule matched in appearance to the active capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or non-pregnant, non-lactating females, 18-60 years of age
- Self-report of good health
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- Willing to maintain current dietary supplement use (e.g., multi-vitamin or other supplements approved by investigator, stimulants excluded) throughout the 28 days of the trial. On test days, participant agrees not to take any of their usual dietary supplements until dismissal from University of Georgia.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
Key exclusion criteria (21 listed)
- Failure to meet any one of the inclusion criteria
- Potential participant will be excluded if the individual is being paid to do work by Dr. O'Connor, is unwilling to comply with safety instructions (e.g., to wear a face covering) or reports:
- Vision problems that cannot be corrected with glasses or contact lenses
- usual daily consumption of ≥ 500 mg caffeine
- Consumption of caffeine or other stimulants, such as stimulant medication commonly used for ADHD (e.g. Ritalin or Adderall), within 12 h of testing. Prescription medications are allowed as long as they do not interfere with testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active capsule1 capsule daily for 28 days | Dietary supplement | 250 mg citicoline |
| Placebo capsule1 capsule daily for 28 days | Other | 0 mg citicoline |
Primary outcome
Errors of commission after 28-day consumption (chronic effect)
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)
17 secondary outcomes
Errors of commission after acute dosing (single dose on Day 1, the first of 28 daily doses)
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Errors of omission after acute dosing
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Errors of omission after chronic dosing
Time frame: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Reaction time after acute dosing
Time frame: Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)
Reaction time after chronic dosing
Time frame: 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
Time frame: Immediately post-dose (baseline Day 1)
For acute study only, sleep behavior the night prior to testing
Time frame: Upon arrival (baseline Day 1)
For the acute study only, motivation to complete the attention task
Time frame: 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
Time frame: 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)
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
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
Time frame: 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
Time frame: Change from post-dose baseline Day 1 to Day 29 measured by
For the chronic study only, sleep behavior the night prior to testing
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
For the chronic study only, motivation to complete the attention task
Time frame: Change from pre-dose baseline Day 1 to Day 29
For the chronic study only, feelings of mental energy and fatigue
Time frame: 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
Time frame: 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
Time frame: Change from pre-dose baseline Day 1 to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J O'Connor, PhD principal investigator
University of Georgia, Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active capsule in people with Attention, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Errors of commission after 28-day consumption (chronic effect) (time frame: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.