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The Combination Effect of Citicoline and Omega-3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444662
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Kyowa Hakko Bio Co., Ltd.

Study Description
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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
Healthy Dietary Supplement: Placebo supplement Dietary Supplement: Citicoline and Omega-3 supplement Dietary Supplement: Omega-3 supplement Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 12, 2018
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo supplement
 Dietary Supplement: Placebo supplement
Cellulose and Sunflower oil
Other Name: 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 Name: Cognizin and Omega-3
Experimental: Omega-3
Intervention: Dietary Supplement: Omega-3 supplement
 Dietary Supplement: Omega-3 supplement
Cellulose and Omega-3
Other Name: Omega-3


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy (percent correct) on an attention task (Conners continuous performance test3) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Scores of Neuropsychological test battery from the Uniform Data Set [ Time Frame: 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 [ Time Frame: 16 weeks ]
  2. Plasma fatty acid levels [ Time Frame: 16 weeks ]
  3. Apolipoprotein E genotype [ Time Frame: Baseline ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444662


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Kyowa Hakko Bio Co., Ltd.
Oregon Health and Science University
More Information
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Responsible Party: Kyowa Hakko Bio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03444662    
Other Study ID Numbers: 16518
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytidine Diphosphate Choline
Nootropic Agents