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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline, Omega-3 Fatty Acids and Creatine | Drug | Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Yurgelun-Todd, PhD | The Brain Institute, University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brain Institute | Salt Lake City | Utah | 84108 | United States |
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| Label | URL |
|---|---|
| Click here for more information about Citicoline | View source |
| Click here for more information about Omega-3 Fatty Acids | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Citicoline, Creatine, and Omega-3 Arm | Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Forty healthy females ranging from 40 to 60 years of age (mean=48.3 ± 5.2) participated in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Citicoline, Creatine, and Omega-3 Arm | Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | score on a scale | Baseline and 14 days from baseline |
|
|
Participants were monitored for the functional effects of citicoline, creatine and omega-3 fatty acids in combination when administered for a duration of four weeks (28 days) at a daily dosage to non-psychiatric adult female subjects. The doses of 500 mg of citicoline, 5 grams of creatine, and 2 grams of omega-3 fatty acids have been selected from previous investigations and have demonstrated minimal side effects.
Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Citicoline, Creatine, and Omega-3 Arm | Citicoline, Omega-3 Fatty Acids and Creatine: Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Yurgelun-Todd, Ph.D. | University of Utah, Diagnostic Neuroimaging Lab | 801-587-1538 | Deborah.Yurgelun-Todd@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2016 | Dec 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| D015525 | Fatty Acids, Omega-3 |
| D003401 | Creatine |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Analyzed participants | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | Score on a scale | Baseline and 28 days from baseline |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |