The Combination Effect of Citicoline and Omega-3

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo supplement; Dietary supplement: Citicoline and Omega-3 supplement; Dietary supplement: Omega-3 supplement

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intervention: Dietary Supplement: Placebo supplement	Dietary supplement: Placebo supplement; Cellulose and Sunflower oil; Other Names: Placebo
Experimental: Cognizin and Omega-3; Intervention: Dietary Supplement: Citicoline and Omega-3 supplement	Dietary supplement: Citicoline and Omega-3 supplement; Citicoline and Omega-3; Other Names: Cognizin and Omega-3
Experimental: Omega-3; Intervention: Dietary Supplement: Omega-3 supplement	Dietary supplement: Omega-3 supplement; Cellulose and Omega-3; Other Names: Omega-3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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	16 weeks
Plasma fatty acid levels	16 weeks
Apolipoprotein E genotype	Baseline

Collaborators and Investigators

• Sponsor: Kyowa Hakko Bio Co., Ltd.
• Collaborators: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents; Cytidine Diphosphate Choline
• Other Study ID Numbers: 16518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No