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CompletedNCT03444662Updated Sep 10, 2019

The Combination Effect of Citicoline and Omega-3

An interventional study of Placebo supplement and Citicoline and Omega-3 supplement in Healthy, sponsored by Kyowa Hakko Bio Co., Ltd.. Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Kyowa Hakko Bio Co., Ltd. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Intervention: Dietary Supplement: Placebo supplement

    Dietary Supplement: Placebo supplement

  • Experimental
    Cognizin and Omega-3

    Intervention: Dietary Supplement: Citicoline and Omega-3 supplement

    Dietary Supplement: Citicoline and Omega-3 supplement

  • Experimental
    Omega-3

    Intervention: Dietary Supplement: Omega-3 supplement

    Dietary Supplement: Omega-3 supplement

Interventions

  • Dietary supplementPlacebo supplement

    Cellulose and Sunflower oil

    Also known as: Placebo

  • Dietary supplementCiticoline and Omega-3 supplement

    Citicoline and Omega-3

    Also known as: Cognizin and Omega-3

  • Dietary supplementOmega-3 supplement

    Cellulose and Omega-3

    Also known as: Omega-3

05

What researchers measure

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

06

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
07

Registry details

Key details

Study ID
NCT03444662
Lead sponsor
Kyowa Hakko Bio Co., Ltd.
Collaborators
Oregon Health and Science University
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Jun 12, 2018
Primary completion
Sep 3, 2019
Completion
Sep 3, 2019
Last update
Sep 10, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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