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

NCT05000190 | Completed

• 1 other identifier: PEP-2101
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

cognition; attention; attentional performance; CPT-III; citicoline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Errors of commission after acute dosing (single dose on Day 1, the first of 28 daily doses)

  Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)

• Errors of omission after acute dosing

  Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)

• Errors of omission after chronic dosing

  Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores

• Reaction time after acute dosing

  Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1)

• Reaction time after chronic dosing

  Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores

Study Arms (2)

250 mg citicoline

EXPERIMENTAL

Opaque capsule

Dietary Supplement: Active capsule

0 mg citicoline

PLACEBO COMPARATOR

Opaque capsule matched in appearance to the active capsule

Other: Placebo capsule

Interventions

Active capsule DIETARY_SUPPLEMENT

1 capsule daily for 28 days

250 mg citicoline

Placebo capsule OTHER

1 capsule daily for 28 days

0 mg citicoline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Patrick J O'Connor, PhD

  University of Georgia, Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: September 13, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)