Cognitive Benefits
Conditions
Keywords
Neuropsychological testing, Dietary supplements
Brief 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.
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.
Interventions
DRUGCiticoline, 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
Sponsors
Deborah Yurgelun-Todd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Citicoline, Creatine, and Omega-3 Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 48.3 years |
| Analyzed participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Baseline and 14 days from baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Citicoline, Creatine, and Omega-3 Arm | Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days | 10 score on a scale |
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.
Time frame: Baseline and 28 days from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Citicoline, Creatine, and Omega-3 Arm | Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days | 98 Score on a scale |