Acute and Chronic Effect of 250 mg Citicoline Consumption on Attention in Adults: A Randomized Trial

NCT ID: NCT05000190

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2022-07-19

Brief 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 has an effect on attentional performance compared to placebo (chronic effect).

Conditions

Attention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

250 mg citicoline

Opaque capsule

Group Type: EXPERIMENTAL

Active capsule

Intervention Type: DIETARY_SUPPLEMENT

1 capsule daily for 28 days

0 mg citicoline

Opaque capsule matched in appearance to the active capsule

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: OTHER

1 capsule daily for 28 days

Interventions

Active capsule

1 capsule daily for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

1 capsule daily for 28 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J O'Connor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia, Athens

Locations

University of Georgia

Athens, Georgia, United States

Countries

United States

Other Identifiers

PEP-2101

Identifier Type: -

Identifier Source: org_study_id