The Combination Effect of Citicoline and Omega-3

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03444662

Enrollment

Registered

2018-02-23

Start date

2018-06-12

Completion date

2019-09-03

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTPlacebo supplement

Cellulose and Sunflower oil

DIETARY_SUPPLEMENTCiticoline and Omega-3 supplement

Citicoline and Omega-3

DIETARY_SUPPLEMENTOmega-3 supplement

Cellulose and Omega-3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026