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

Not Applicable

Completed

• Conditions: Cognitive Benefits
• Interventions: Drug: Citicoline, Omega-3 Fatty Acids and Creatine

• Registration Number: NCT01502813
• Lead Sponsor: Deborah Yurgelun-Todd

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.

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2012-01-02
• Study Start: 2012-02-01
• Primary Completion: 2018-10-30
• Study Completion: 2019-11-01
• Results First Submitted: 2019-12-10
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-20
• Last Update Submitted: 2021-04-20
• Results First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Citicoline, Creatine, and Omega-3 Arm	Citicoline, Omega-3 Fatty Acids and Creatine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Brain Institute; 🇺🇸 Salt Lake City, Utah, United States