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临床试验/NCT01669200
NCT01669200已完成不适用

Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Improvement in cognitive performance

研究概览

简要总结

The primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive performance.

详细描述

Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit followed by six post-baseline visits. The control and placebo groups will each be comprised of ten subjects randomly assigned to the groups. The assessments at baseline will include concomitant medications, vital signs, height, and weight. In addition, subjects will complete a medical history questionnaire, and receive group instruction on incorporation of the study products into the diet from a registered dietitian. Study products will be dispensed at each visit in excess of requirements, and re-issued at every visit after measurement of the remaining product that subjects will be instructed to bring to every visit. The post-baseline study visits will include body weight and vital sign measurements, concomitant medications, dispensation of study products, group instruction by a registered dietitian, and an assessment for adverse events.

Between study visits the subjects will receive a telephone call from the study coordinator to encourage compliance with the diet, and to ask about any adverse events. The study visits will conclude at week 24. The psychological tests conducted by clinicians at screening will be repeated during the cognitive testing visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are male or female with a diagnosis of Mild Cognitive Impairment
  • Are 50 years of age or older

排除标准

  • Been on medication for Mild Cognitive Impairment less than 90 days
  • Major depression
  • Uncontrolled hypothyroidism
  • Known B12 deficiency
  • Hepatic (liver) disease or insufficiency

结局指标

主要结局

Improvement in cognitive performance

时间窗: Assess in subjects at Baseline to week 24 using different Cognitive testing scores.

Daily dosing of in subjects with Medium Chain Triglyceride Oil will change cognition scores measured at baseline to the end of week 24 using cognitive testing results. (ADAS-Cog, Trails Making Test, Mini Mental State Exam, Digit Symbol Test and Short-Form 36 Health Survey).

次要结局

  • Serum Ketones(Baselines to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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