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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah
ClinicalTrials.gov Identifier:
NCT01502813
First received: December 20, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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 Intervention
Cognitive Benefits
Drug: Citicoline, Omega-3 Fatty Acids and Creatine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change from Baseline in Neuropsychological Tests that measure attention and memory at 14 days [ Time Frame: Baseline and 14 days from baseline ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Neuropsychological Tests that measure attention and memory at 28 days [ Time Frame: Baseline and 28 days from baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Deborah Yurgelun-Todd, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT01502813     History of Changes
Other Study ID Numbers: IRB_48136
Study First Received: December 20, 2011
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Neuropsychological testing
Dietary supplements

Additional relevant MeSH terms:
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014