The Combination Effect of Citicoline and Omega-3

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo supplement; Dietary Supplement: Citicoline and Omega-3 supplement; Dietary Supplement: Omega-3 supplement

• Registration Number: NCT03444662
• Lead Sponsor: Kyowa Hakko Bio Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-23
• Study Start: 2018-06-12
• Status Verified: 2019-04
• Primary Completion: 2019-09-03
• Study Completion: 2019-09-03
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo supplement	Intervention: Dietary Supplement: Placebo supplement
Cognizin and Omega-3	Citicoline and Omega-3 supplement	Intervention: Dietary Supplement: Citicoline and Omega-3 supplement
Omega-3	Omega-3 supplement	Intervention: Dietary Supplement: Omega-3 supplement

Primary Outcome Measures

Name	Time	Method
Accuracy (percent correct) on an attention task (Conners continuous performance test3)	16 weeks

Secondary Outcome Measures

Name	Time	Method
Scores of Neuropsychological test battery from the Uniform Data Set	16 weeks

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States