The Brain Institute
Salt Lake City, Utah, 84108, United States
Completed
NCT Number: NCT01502813
Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
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.
Completed
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Notify MeKey information
Conditions
Age range
40 year–60 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Female
- Age 40-60 years
Exclusion criteria
- 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
- History of fish allergies
- Medical condition associated with clinically significant decreases in coagulability
- Use of anticoagulant medication
Treatment and study plan
Citicoline, Omega-3 Fatty Acids and Creatine
DrugCiticoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
Other names: CDP-Citicoline, Creatine monohydrate
Primary outcomes
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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.
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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.
Sponsors and collaborators
Lead sponsor
Deborah Yurgelun-Todd
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Jan 2, 2012
- Registry last updated
- Apr 22, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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