The Combination Effect of Citicoline and Omega-3

Kyowa Hakko Bio

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Omega-3 supplement; Dietary Supplement: Citicoline and Omega-3 supplement; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03444662

16518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 55+ years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

70 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intervention: Dietary Supplement: Placebo supplement

Treatment:

Dietary Supplement: Placebo supplement

Cognizin and Omega-3

Experimental group

Description:

Intervention: Dietary Supplement: Citicoline and Omega-3 supplement

Treatment:

Dietary Supplement: Citicoline and Omega-3 supplement

Omega-3

Experimental group

Description:

Intervention: Dietary Supplement: Omega-3 supplement

Treatment:

Dietary Supplement: Omega-3 supplement