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临床试验/NCT02775084
NCT02775084已完成不适用

Nutritional Intervention to Test Effect on Healthy Human T Cell Function

Texas A&M University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Change in function of of lipid rafts in immune cell membranes due to dietary polyunsaturated fatty acids supplementation

研究概览

简要总结

The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half of the participants will receive fish oil, while the other half will receive a placebo (olive oil).

详细描述

Generalized inflammation has been consistently associated with aging and metabolic diseases, often characterized by reduced muscle and cognitive function. Although much of the aging-associated inflammation has been attributed to chronic activation of the innate host defense system, activated CD4+ T cells have been shown to contribute directly to the pathogenesis of several other inflammatory diseases. In humans, dietary n-3 polyunsaturated fatty acids (PUFA), particularly docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have anti-inflammatory properties and reduce disease symptoms, in part, through suppression of CD4+ T cell activation. Therefore, the Researchers' overall hypothesis is that dietary supplementation with DHA and EPA in humans will ameliorate inflammatory symptoms, in part, by suppressing CD4+ T cell activation, positively affecting muscle and cognitive function.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Olive Oil

Placebo Comparator

8 grams olive oil

干预措施: Olive Oil (Dietary Supplement)

Healthy Fish Oil

Experimental

8 grams fish oil

干预措施: Fish Oil (Dietary Supplement)

结局指标

主要结局

Change in function of of lipid rafts in immune cell membranes due to dietary polyunsaturated fatty acids supplementation

时间窗: one time on baseline, day 21 and day 42

one blood draw on each study visit

次要结局

  • Fatty acid metabolism(one time on baseline, day 21 and day 42)
  • Body Composition(15 minutes on baseline, day 21 and day 42)
  • Diet recall(on baseline and change from day 21 and day 42)
  • Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Group differences in learning and memory as measured by Digit Span(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Executive Function-Adolescent/Adult Sensory Profile (ASP)(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Group differences in attention and executive functions as measured by Brief-A(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Group differences in attention and executive functions as measured by Trail Making Test (TMT)(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42)
  • Skeletal muscle strength of leg(30 minutes on baseline, day 21 and day 42)
  • Skeletal muscle strength of hand(30 minutes on baseline, day 21 and day 42)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marielle PKJ Engelen, PhD

Associate Professor

Texas A&M University

研究点 (2)

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