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临床试验/NCT01621646
NCT01621646已完成不适用

The Effect of Consumption of 2 Eggs or 4 oz of Egg Substitute Daily for 6 Months on Cognitive Function in Older Adults.

Tufts University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2012年7月1日最近更新:
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
44
试验地点
1
主要终点
cognition

研究概览

简要总结

Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from our studies suggest that the carotenoids, lutein and zeaxanthin may be important in cognitive function in the elderly. The investigators have previously reported eggs to be a highly bioavailable source of lutein and zeaxanthin. Our study evaluates long-term egg intervention as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia. The investigators have also shown that lutein supplementation significantly improved verbal fluency scores in healthy older women. Our studies have shown that egg interventions can significantly increase serum lutein concentrations in older adults. Based on the sum of our findings, the next logical step will be to investigate the ability of lutein and zeaxanthin contained in eggs to influence cognitive function in older adults. The investigators hypothesize that there will be a significant increase in cognitive function measures in older adults provided with meals containing 2 egg/day at the end of 6 months, while no significant improvements will be observed in older adults given daily meals containing egg substitute.

The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 2 eggs/day on cognitive function in older adults. Secondary analyses will determine whether baseline MP density predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.

详细描述

The study is designed as a placebo controlled trial that tests the effects of 6 month supplementation with 2 eggs or 4 ounces of egg substitute a day on cognitive function in older adults. Subjects will be randomly assigned to one of the two groups. Secondary analyses will determine whether baseline macular pigment density (a non invasive measure of lutein and zeaxanthin in neural tissue) or choline status predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation, choline bioavailability, and genetic variants related to endogenous choline production. Participants will be recruited from community-dwelling men and women aged > 50 yr, and potential participants will be screened to meet cognitive and functional criteria. Participants will be pre-screened by telephone; those who appear to meet criteria will undergo further screening. The study will include baseline (0 month), 3 and 6 month visits for study procedures, and monthly telephone calls. Given that there is a visible difference between the two interventions (eggs, egg substitute), a blinded study is not possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •men and women age > 50 years
  • •BMI 19-30 kg/m2
  • •lutein intake of < 3 mg/d
  • •DHA (docosahexaehoic acid) intake < 250 mg/d (including supplements)
  • •Mini mental state exam (MMSE) score > 24 (Appendix B)
  • •macular pigment density < 0.5 at 0.5 degrees
  • •Beck Depression Inventory < 20
  • •free of known disease;
  • •BMI 19-29 kg/m2
  • •must be able to give written informed consent
  • •have normal hematologic parameters
  • •normal values of plasma albumin
  • •normal values for liver and kidney function (Appendix A)
  • •no use of carotenoid, n3 fatty acid, multivitamin/mineral, or choline supplements (> 3 months).

排除标准

  • 未提供

研究组 & 干预措施

egg white (control)

Placebo Comparator

egg whites, 4 ounces per day for six months

干预措施: eggs or egg whites (Other)

eggs

Experimental

eggs, 2 large per day for 6 months

干预措施: eggs or egg whites (Other)

结局指标

主要结局

cognition

时间窗: 6 months

measures of attention, executive function, verbal fluency will be made using a sensitive computerized program

次要结局

  • inflammation(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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