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

April 20, 2021 updated by: Deborah Yurgelun-Todd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • The Brain Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Citicoline, Creatine, and Omega-3 Arm
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
Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
Other Names:
  • CDP-Citicoline
  • Creatine monohydrate

What is the study measuring?

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
Time Frame: 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.
Baseline and 14 days from baseline
Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days
Time Frame: 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.
Baseline and 28 days from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deborah Yurgelun-Todd

Investigators

  • Principal Investigator: Deborah Yurgelun-Todd, PhD, The Brain Institute, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_48136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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