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临床试验/NCT04551937
NCT04551937已完成不适用

The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Biological markers of stress

研究概览

简要总结

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.

详细描述

Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive function. Pertinent to the proposed work, dietary intake has been recently shown to have the potential to directly influence the gut microbiota composition as well as brain function. Specifically, the consumption of prebiotics or fibers metabolized by gut bacteria may also play a role. These foods are readily available in the marketplace, however, their implications for physical and cognitive function are not clear. Accordingly, the proposed study aims to investigate effects of prebiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blind (participant and investigative team)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • Between the ages of 25-45 years at the time of consent
  • BMI ≥18.5 kg/m2
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task.
  • Ability to drop-off fecal sample within 15 minutes of defecation

排除标准

  • Current pregnancy or lactation
  • Tobacco use
  • Dairy allergy or intolerance
  • Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
  • Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease
  • Use of any anti-psychotic, anti-depressant, antianxiety, or ADD/ADHD medications
  • Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antispasmodics, diuretics, anticonvulsants).
  • Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)

结局指标

主要结局

Biological markers of stress

时间窗: 4-5 weeks

Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).

Behavioral markers of stress

时间窗: 4-5 weeks

Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.

次要结局

  • Gastrointestinal Microbiota composition(4-5 weeks)
  • Cognitive function(4-5 weeks)
  • Gastrointestinal Microbiota alpha-diversity(4-5 weeks)
  • Gastrointestinal microbiota beta-diversity(4-5 weeks)
  • Sleep(4-5 weeks)

研究者

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

Hannah Holscher

Assistant Professor of Nutrition

University of Illinois at Urbana-Champaign

研究点 (2)

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