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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

September 4, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Change from Baseline in Neuropsychological Tests that measure attention and memory at 14 days [ Time Frame: 14 days ] [ 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: 28 days ] [ 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.

Change History

Complete list of historical versions of study NCT01502813 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cognitive Benefits

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01502813

Other Study ID Numbers ^ICMJE

IRB_48136

Has Data Monitoring Committee

Yes

Responsible Party

Deborah Yurgelun-Todd, University of Utah

Study Sponsor ^ICMJE

Deborah Yurgelun-Todd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Deborah Yurgelun-Todd, PhD

The Brain Institute, University of Utah

Information Provided By

University of Utah

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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