Clinical trial NCT03444662: The Combination Effect of Citicoline and Omega-3
Official title: The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kyowa Hakko Bio Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
First posted: 2018-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Accuracy (percent correct) on an attention task (Conners continuous performance test3)
timeFrame: 16 weeks
Secondary outcomes:
measure: Scores of Neuropsychological test battery from the Uniform Data Set
timeFrame: 16 weeks
Other outcomes:
measure: 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
timeFrame: 16 weeks
measure: Plasma fatty acid levels
timeFrame: 16 weeks
measure: Apolipoprotein E genotype
timeFrame: Baseline
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: