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临床试验/NCT01502813
NCT01502813已完成不适用

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

Deborah Yurgelun-Todd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 40-60 years

排除标准

  • 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

研究组 & 干预措施

Citicoline, Creatine, and Omega-3 Arm

Experimental

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participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study.

干预措施: Citicoline, Omega-3 Fatty Acids and Creatine (Drug)

结局指标

主要结局

Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days

时间窗: Baseline and 14 days from baseline

List B in the California Verbal Learning Test (CVLT) score range 1-16; the score is the number of words recalled so higher scores = better performance/more words recalled.

Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days

时间窗: Baseline and 28 days from baseline

WAIS-IV Block Design Subtest A test of visuoconstructional ability is recognized as a test of visuospatial planning and function. It has been shown to be correlated with measures of general intellectual ability. The score range for this measure is 0-129. A score of 90-110 is average for a standard score. The higher the score the better the outcome.

次要结局

未报告次要终点

研究者

发起方
Deborah Yurgelun-Todd
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deborah Yurgelun-Todd

Professor of Psychiatry

University of Utah

研究点 (1)

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