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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Benefits

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study.

Group Type EXPERIMENTAL

Citicoline, Omega-3 Fatty Acids and Creatine

Intervention Type DRUG

Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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CDP-Citicoline Creatine monohydrate

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes