Trial Outcomes & Findings for Citicoline, Creatine, and Omega-3 Effects in Middle Age Women (NCT NCT01502813)

Last Updated: 2021-04-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 14 days from baseline

Results posted on

2021-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citicoline, Creatine, and Omega-3 Arm n=40 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.3 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Analyzed participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Citicoline, Creatine, and Omega-3 Arm n=40 Participants 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
Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days	10 score on a scale Interval 1.0 to 16.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Citicoline, Creatine, and Omega-3 Arm n=40 Participants 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
Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days	98 Score on a scale Interval 0.0 to 130.0

Adverse Events

Citicoline, Creatine, and Omega-3 Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah Yurgelun-Todd, Ph.D.

University of Utah, Diagnostic Neuroimaging Lab

Phone: 801-587-1538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place