Cognitive BenefitsNCT01502813
Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
A study testing Citicoline, Omega-3 Fatty Acids and Creatine in people with Cognitive Benefits, run by Deborah Yurgelun-Todd at 1 site in United States.
Trial summary
The purpose of this study is to determine the functional effects of a citicoline, creatine, and omega-3 fatty acids combination when administered for a duration of four weeks (28 days) to non-psychiatric adult female participants. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Benefits
- What is being tested?
- Citicoline, Omega-3 Fatty Acids and Creatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2012to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age 40-60 years
Who cannot join
- Significant medical condition
- History of co-morbid psychiatric disorders
- Current Axis I or II diagnosis
- Past participation in a pharmacotherapeutic trial
- Head injury with LOC>5 minutes
- Use of psychotropic medication
Show all 9Show fewer
- History of fish allergies
- Medical condition associated with clinically significant decreases in coagulability
- Use of anticoagulant medication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the functional effects of a citicoline, creatine, and omega-3 fatty acids combination when administered for a duration of four weeks (28 days) to non-psychiatric adult female participants.
Read the detailed description
Standard clinical measures for mood and neuropsychological measures of attention, cognitive inhibition and memory will be applied before, during, and after a course of a daily supplementation of citicoline, creatine and omega-3 for 28 days to non-psychiatric adult female participants. We hypothesis that the combination of supplements will improve memory and attention in healthy adult women.
- Conditions
- Cognitive Benefits
- Being tested
- Citicoline, Omega-3 Fatty Acids and Creatine
- Keywords
- Neuropsychological testing, Dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline, Omega-3 Fatty Acids and CreatineDrug
Also called CDP-Citicoline, Creatine monohydrate
Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Citicoline, Creatine, and Omega-3 Arm | Experimental | Each participant will be given a supplement log at the end of visit 1. They will be asked to complete the log during the 28 days to indicate that the daily dose of supplements were taken according to instructions. The study coordinator will check the log on the second and third visits as well as count the remaining supplement pills. If participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study. Receives: Drug: Citicoline, Omega-3 Fatty Acids and Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days
List B in the California Verbal Learning Test (CVLT) score range 1-16; the score is the number of words recalled so higher scores = better performance/more words recalled.
Measured: Baseline and 14 days from baseline
Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days
WAIS-IV Block Design Subtest A test of visuoconstructional ability is recognized as a test of visuospatial planning and function. It has been shown to be correlated with measures of general intellectual ability. The score range for this measure is 0-129. A score of 90-110 is average for a standard score. The higher the score the better the outcome.
Measured: Baseline and 28 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study start1 Feb 2012
- Primary completion30 Oct 2018
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive BenefitsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Yurgelun-Todd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Yurgelun-Todd, University of Utah
- Investigators
- Deborah Yurgelun-Todd, PhD, Principal investigator, The Brain Institute, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502813
- Sponsor's protocol ID
- IRB_48136
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2011
- Last updated
- 22 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
- ClinicalTrials.gov ID
- NCT01502813
- Acronym / sponsor ID
- IRB_48136
- Conditions
- Cognitive Benefits
- Keywords
- Neuropsychological testing, Dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Deborah Yurgelun-ToddUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Posted 22 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the functional effects of a citicoline, creatine, and omega-3 fatty acids combination when administered for a duration of four weeks (28 days) to non-psychiatric adult female participants.
Detailed description
Standard clinical measures for mood and neuropsychological measures of attention, cognitive inhibition and memory will be applied before, during, and after a course of a daily supplementation of citicoline, creatine and omega-3 for 28 days to non-psychiatric adult female participants. We hypothesis that the combination of supplements will improve memory and attention in healthy adult women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Citicoline, Creatine, and Omega-3 Arm | Experimental | Drug: Citicoline, Omega-3 Fatty Acids and CreatineEach participant will be given a supplement log at the end of visit 1. They will be asked to complete the log during the 28 days to indicate that the daily dose of supplements were taken according to instructions. The study coordinator will check the log on the second and third visits as well as count the remaining supplement pills. If participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Age 40-60 years
Key exclusion criteria (9 listed)
- Significant medical condition
- History of co-morbid psychiatric disorders
- Current Axis I or II diagnosis
- Past participation in a pharmacotherapeutic trial
- Head injury with LOC>5 minutes
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 |
|---|---|---|
| Citicoline, Omega-3 Fatty Acids and CreatineAlso: CDP-Citicoline, Creatine monohydrateCiticoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days | Drug | Citicoline, Creatine, and Omega-3 Arm |
Primary outcome
Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days
Time frame: Baseline and 14 days from baseline
List B in the California Verbal Learning Test (CVLT) score range 1-16; the score is the number of words recalled so higher scores = better performance/more words recalled.
Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days
Time frame: Baseline and 28 days from baseline
WAIS-IV Block Design Subtest A test of visuoconstructional ability is recognized as a test of visuospatial planning and function. It has been shown to be correlated with measures of general intellectual ability. The score range for this measure is 0-129. A score of 90-110 is average for a standard score. The higher the score the better the outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about CiticolineLink provided by the sponsor.
- Click here for more information about Omega-3 Fatty AcidsLink provided by the sponsor.
Related trials for Cognitive Benefits
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Active, not recruiting
Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease
Parkinson Disease
Not yet recruitingObservational study
A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease
Alzheimers Disease
Active, not recruiting
The Effects, Usability, Satisfaction, Barriers, and Benefits of a Remote, Multidomain Website-based Intervention to Prevent Cognitive Decline in Older Adults
Coginitive Dysfunction
Not yet recruiting
Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias
Alzheimer Disease, Dementia
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.
Deborah Yurgelun-Todd, PhD principal investigator
The Brain Institute, University of Utah
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, Omega-3 Fatty Acids and Creatine in people with Cognitive Benefits, run by Deborah Yurgelun-Todd 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 2 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 22 Apr 2021. 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. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days (time frame: Baseline and 14 days from baseline). The study lists 2 primary outcomes in all. 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 22 Apr 2021.