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Completed

NCT Number: NCT03444662

The Combination Effect of Citicoline and Omega-3

The goal of this study is to determine the effects of Citicoline plus Omega-3 or Omega-3 alone versus placebo on attention in non-demented healthy older adults.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

This study is a randomized, double-blind, placebo-controlled trial. The investigators hypothesize that supplementation of Citicoline plus Omega-3 will improve attention in healthy adults age 55 years and older, compared to placebo. The study is designed as 3-arm, parallel group study comparing placebo, Omega-3 only, and Citicoline plus Omega-3.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 55 years or older
  • If female, must be post-menopausal
  • Non-demented
  • Not depressed
  • General health status that will not interfere with the participant's ability to complete the study
  • No history of neurological disorder
  • Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
  • Sufficient English language skills to complete all testing

Exclusion criteria

  • Alzheimer's, Dementia or other neurological disease
  • Fish intake of 6 ounce serving once a week 3 months prior to enrollment; Omega-3 supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 3 months prior to enrollment.
  • Citicoline supplementation 3 months prior to enrollment
  • Prescriptions medications:
  • Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven), Factor Xa inhibitors: rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis); Low molecular weight heparins: dalteparin (fragmin), enoxaparin (lovenox)
  • Dementia medications (e.g. anticholinesterase inhibitors, memantine)
  • Diagnosis of Adult Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) and/or taking stimulants (e.g. dextroamphetamine sulfate, methylphenidate HCL, dextroamphetamine Sulf-Saccharate)
  • Body Mass Index > 30
  • Enrollment in another treatment study

Treatment and study plan

Placebo supplement

Dietary Supplement

Cellulose and Sunflower oil

Other names: Placebo

Citicoline and Omega-3 supplement

Dietary Supplement

Citicoline and Omega-3

Other names: Cognizin and Omega-3

Omega-3 supplement

Dietary Supplement

Cellulose and Omega-3

Other names: Omega-3

Primary outcomes

  1. Accuracy (percent correct) on an attention task (Conners continuous performance test3)

    Time frame: 16 weeks

Secondary outcomes

  1. Scores of Neuropsychological test battery from the Uniform Data Set

    Time frame: 16 weeks

Other outcomes

  1. Number of participants with treatment-related adverse events as monitored by recording a comprehensive metabolic panel, complete blood count and prothrombin time-international normalized ratio

    Time frame: 16 weeks

  2. Plasma fatty acid levels

    Time frame: 16 weeks

  3. Apolipoprotein E genotype

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Kyowa Hakko Bio Co., Ltd.

Industry

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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