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The Combination Effect of Citicoline and Omega-3

Sponsor
Kyowa Hakko Bio Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03444662
Collaborator
Oregon Health and Science University (Other)
70
Enrollment
1
Location
3
Arms
14.7
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo supplement
  • Dietary Supplement: Citicoline and Omega-3 supplement
  • Dietary Supplement: Omega-3 supplement
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
Actual Study Start Date :
Jun 12, 2018
Actual Primary Completion Date :
Sep 3, 2019
Actual Study Completion Date :
Sep 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Intervention: Dietary Supplement: Placebo supplement

Dietary Supplement: Placebo supplement
Cellulose and Sunflower oil
Other Names:
  • Placebo

    		•
    Experimental: Cognizin and Omega-3

    Intervention: Dietary Supplement: Citicoline and Omega-3 supplement

    Dietary Supplement: Citicoline and Omega-3 supplement
    Citicoline and Omega-3
    Other Names:
  • Cognizin and Omega-3

    		•
    Experimental: Omega-3

    Intervention: Dietary Supplement: Omega-3 supplement

    Dietary Supplement: Omega-3 supplement
    Cellulose and Omega-3
    Other Names:
  • Omega-3

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Other Outcome Measures

    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 [16 weeks]

    2. Plasma fatty acid levels [16 weeks]

    3. Apolipoprotein E genotype [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Kyowa Hakko Bio Co., Ltd.
    • Oregon Health and Science University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Hakko Bio Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03444662
    Other Study ID Numbers:
    • 16518
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    Sep 10, 2019
    Last Verified:
    Apr 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cytidine Diphosphate Choline

    Study Results

    No Results Posted as of Sep 10, 2019