The Combination Effect of Citicoline and Omega-3

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo supplement
* Dietary Supplement: Citicoline and Omega-3 supplement
* Dietary Supplement: Omega-3 supplement


Participation Criteria
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Eligibility Criteria
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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: 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) Dementia medications (e.g. anticholinesterase inhibitors, memantine) 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intervention: Dietary Supplement: Placebo supplement | Dietary Supplement: Placebo supplement<br>* Cellulose and Sunflower oil<br>* Other names: Placebo;|
| Experimental: Cognizin and Omega-3<br>Intervention: Dietary Supplement: Citicoline and Omega-3 supplement | Dietary Supplement: Citicoline and Omega-3 supplement<br>* Citicoline and Omega-3<br>* Other names: Cognizin and Omega-3;|
| Experimental: Omega-3<br>Intervention: Dietary Supplement: Omega-3 supplement | Dietary Supplement: Omega-3 supplement<br>* Cellulose and Omega-3<br>* Other names: Omega-3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (percent correct) on an attention task (Conners continuous performance test3) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of Neuropsychological test battery from the Uniform Data Set |  | 16 weeks |