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The Combination Effect of Citicoline and Omega-3

NCT03444662 — Not applicable, Completed, 70 participants, Kyowa Hakko Bio Co., Ltd.

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

RegistryNCT03444662
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, basic science
Enrollment70 (Actual)
SponsorKyowa Hakko Bio Co., Ltd. (Industry); collaborators: Oregon Health and Science University
ConditionsHealthy
InterventionsPlacebo supplement, Citicoline and Omega-3 supplement, Omega-3 supplement (Dietary supplement)
Datesstart 2018-06-12, primary completion 2019-09-03, completion 2019-09-03, first posted 2018-02-23, last updated 2019-09-10
Locations1 site in United States

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-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorDietary Supplement: Placebo supplementIntervention: Dietary Supplement: Placebo supplement
Cognizin and Omega-3ExperimentalDietary Supplement: Citicoline and Omega-3 supplementIntervention: Dietary Supplement: Citicoline and Omega-3 supplement
Omega-3ExperimentalDietary Supplement: Omega-3 supplementIntervention: Dietary Supplement: Omega-3 supplement
  • Placebo supplement (Dietary supplement), also known as Placebo: Cellulose and Sunflower oil
  • Citicoline and Omega-3 supplement (Dietary supplement), also known as Cognizin and Omega-3: Citicoline and Omega-3
  • Omega-3 supplement (Dietary supplement), also known as Omega-3: Cellulose and Omega-3

+Outcome measures

Primary outcomes

  • Accuracy (percent correct) on an attention task (Conners continuous performance test3) [16 weeks]

Secondary outcomes

  • Scores of Neuropsychological test battery from the Uniform Data Set [16 weeks]

Other outcomes

  • 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 [16 weeks]
  • Plasma fatty acid levels [16 weeks]
  • Apolipoprotein E genotype [Baseline]

+Eligibility

Sex: All, ages: 55 Years to any, accepts healthy volunteers

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:

  1. 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)
  2. Dementia medications (e.g. anticholinesterase inhibitors, memantine)
  3. 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

+Locations (1)

FacilityCityCountryStatus
Oregon Health & Science UniversityPortland, OregonUnited States

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