Citicoline, Creatine, and Omega-3 Effects in Middle Age Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Citicoline, Creatine, and Omega-3 Effects in Middle Age Women

Conditions
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Cognitive Benefits

Intervention / Treatment
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* Drug: Citicoline, Omega-3 Fatty Acids and Creatine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citicoline, Creatine, and Omega-3 Arm<br>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. | Drug: Citicoline, Omega-3 Fatty Acids and Creatine<br>* Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days<br>* Other names: Creatine monohydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and 28 days from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropsychological testing, Dietary supplements