HealthyNCT03444662
The Combination Effect of Citicoline and Omega-3
A study testing Citicoline and Omega-3 supplement and Omega-3 supplement in people with Healthy, run by Kyowa Hakko Bio Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Citicoline and Omega-3 supplement and Omega-3 supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 3 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Placebo supplement, Citicoline and Omega-3 supplement, Omega-3 supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementDietary supplement
Also called Placebo
Cellulose and Sunflower oil
Citicoline and Omega-3 supplementDietary supplement
Also called Cognizin and Omega-3
Citicoline and Omega-3
Omega-3 supplementDietary supplement
Also called Omega-3
Cellulose and Omega-3
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention: Dietary Supplement: Placebo supplement Receives: Dietary Supplement: Placebo supplement |
| Cognizin and Omega-3 | Experimental | Intervention: Dietary Supplement: Citicoline and Omega-3 supplement Receives: Dietary Supplement: Citicoline and Omega-3 supplement |
| Omega-3 | Experimental | Intervention: Dietary Supplement: Omega-3 supplement Receives: Dietary Supplement: Omega-3 supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (percent correct) on an attention task (Conners continuous performance test3)
Measured: 16 weeks
Secondary outcomes (1)
Scores of Neuropsychological test battery from the Uniform Data Set
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start12 Jun 2018
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444662
- Sponsor's protocol ID
- 16518
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03444662
- Acronym / sponsor ID
- 16518
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementIntervention: Dietary Supplement: Placebo supplement |
| Cognizin and Omega-3 | Experimental | Dietary Supplement: Citicoline and Omega-3 supplementIntervention: Dietary Supplement: Citicoline and Omega-3 supplement |
| Omega-3 | Experimental | Dietary Supplement: Omega-3 supplementIntervention: Dietary Supplement: Omega-3 supplement |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- Body Mass Index > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo supplementAlso: PlaceboCellulose and Sunflower oil | Dietary supplement | Placebo |
| Citicoline and Omega-3 supplementAlso: Cognizin and Omega-3Citicoline and Omega-3 | Dietary supplement | Cognizin and Omega-3 |
| Omega-3 supplementAlso: Omega-3Cellulose and Omega-3 | Dietary supplement | Omega-3 |
Primary outcome
Accuracy (percent correct) on an attention task (Conners continuous performance test3)
Time frame: 16 weeks
1 secondary outcome
Scores of Neuropsychological test battery from the Uniform Data Set
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline and Omega-3 supplement and Omega-3 supplement in people with Healthy, run by Kyowa Hakko Bio Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (percent correct) on an attention task (Conners continuous performance test3) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.