The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
| Registry | NCT03444662 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, basic science |
| Enrollment | 70 (Actual) |
| Sponsor | Kyowa Hakko Bio Co., Ltd. (Industry); collaborators: Oregon Health and Science University |
| Conditions | Healthy |
| Interventions | Placebo supplement, Citicoline and Omega-3 supplement, Omega-3 supplement (Dietary supplement) |
| Dates | start 2018-06-12, primary completion 2019-09-03, completion 2019-09-03, first posted 2018-02-23, last updated 2019-09-10 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplement | Intervention: Dietary Supplement: Placebo supplement |
| Cognizin and Omega-3 | Experimental | Dietary Supplement: Citicoline and Omega-3 supplement | Intervention: Dietary Supplement: Citicoline and Omega-3 supplement |
| Omega-3 | Experimental | Dietary Supplement: Omega-3 supplement | Intervention: Dietary Supplement: Omega-3 supplement |
Sex: All, ages: 55 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Oregon Health & Science University | Portland, Oregon | United States |