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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Utah.
Recruitment status was  Active, not recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014