跳至主要内容
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2012年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Mild Cognitive Impairment
发起方
Tufts University
入组人数
44
试验地点
1
主要终点
cognition
状态
已完成
最后更新
8年前

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.

注册库
clinicaltrials.gov
开始日期
2012年7月
结束日期
2015年8月
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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

排除标准

  • 未提供

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)

研究点 (1)

Loading locations...

相似试验