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

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ClinicalTrials.gov Identifier: NCT01502813
Recruitment Status : Active, not recruiting
First Posted : January 2, 2012
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah

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.

Condition or disease Intervention/treatment Phase
Cognitive Benefits Drug: Citicoline, Omega-3 Fatty Acids and Creatine Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2012
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Citicoline, Creatine, and Omega-3 Arm 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



Primary Outcome Measures :
  1. Change from Baseline in Neuropsychological Tests that measure attention and memory at 14 days [ Time Frame: Baseline and 14 days from baseline ]
    Neuropsychological testing will be administered during baseline and at 14 days. The testing will be used to evaluate the effect of the supplements on memory and attention.

  2. Change from Baseline in Neuropsychological Tests that measure attention and memory at 28 days [ Time Frame: Baseline and 28 days from baseline ]
    Neuropsychological testing will be administered during baseline and at 28 days. The testing will be used to evaluate the effect of the supplements on memory and attention.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502813


Locations
United States, Utah
The Brain Institute
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Deborah Yurgelun-Todd
Investigators
Principal Investigator: Deborah Yurgelun-Todd, PhD The Brain Institute, University of Utah

Additional Information:
Responsible Party: Deborah Yurgelun-Todd, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT01502813     History of Changes
Other Study ID Numbers: IRB_48136
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Deborah Yurgelun-Todd, University of Utah:
Neuropsychological testing
Dietary supplements

Additional relevant MeSH terms:
Cytidine Diphosphate Choline
Nootropic Agents