Status:
COMPLETED
The Combination Effect of Citicoline and Omega-3
Lead Sponsor:
Kyowa Hakko Bio Co., Ltd.
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Healthy
Eligibility:
All Genders
55+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03444662
Start Date
June 12 2018
End Date
September 3 2019
Last Update
September 10 2019
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239