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临床试验/NCT04257201
NCT04257201已完成不适用

Mushroom Ingestion Study

Purdue University2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年8月15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
7
试验地点
2
主要终点
Plasma ergothioneine

研究概览

简要总结

The investigators propose to determine the effect of consuming 0, 1 or 2 servings of white button (Agaricus bisporus; most popular, lower ergothioneine) or yellow oyster (Pleurotus citrinopileatus; higher ergothioneine) mushrooms on postprandial changes in plasma levels and urinary excretions of mushroom-specific compounds.

详细描述

The investigators hypothesize that consuming different mushroom varieties will elicit distinct postprandial nutrimetabolomic profiles in the plasma and urine and that the amount of metabolites present will increase with the servings of mushrooms. Measuring ergothioneine in the plasma will provide a quantitative outcome to document the postprandial responses to consuming the test meals. The nutrimetabolomic related outcomes are exploratory and have not been documented in human research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female;
  • age 30-69 y;
  • BMI: 25.0-34.9 kg/m2;
  • Not severely or extremely depressed (Beck's Depression Inventory score ≤30)
  • Total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, fasting glucose <110 mg/dL;
  • Systolic/diastolic blood pressure <140/90 mm Hg;
  • Body weight stable for 3 months prior (± 3 kg);
  • Stable physical activity regimen 3 months prior;
  • Medication use stable for 6 months prior;
  • Non-smoking;
  • Non-diabetic;
  • Not acutely ill;
  • Females not pregnant or lactating;
  • Participants must be willing and able to consume the prescribed diets and travel to testing facilities.

排除标准

  • BMI <25 or >35;
  • Severely depressed (Beck's Depression Inventory score >30);
  • Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, fasting glucose >110 mg/dL;
  • Body weight changes in previous 3 months (±3 kg);
  • Changes in physical activity regimen in the previous 3 months;
  • Medication changes in the previous 6 months;
  • Diabetic;
  • Acute illness;
  • Pregnant or lactating;
  • Allergic to mushrooms

结局指标

主要结局

Plasma ergothioneine

时间窗: 5 hours

Plasma will be assessed for ergothioneine concentration, a compound unique to mushrooms

Plasma triglycerides

时间窗: 5 hours

Plasma will be assessed for triglyceride values at the time of salad consumption and at each hour for 5 hours after salad consumption

Change in plasma insulin

时间窗: 5 hours

Plasma will be assessed for insulin values prior to salad consumption and in response to the test day meal

Change in plasma glucose

时间窗: 5 hours

Plasma will be assessed for glucose values prior to salad consumption and in response to the test day meal

Plasma metabolomics

时间窗: 5 hours

Plasma will be assessed for metabolomics (i.e. ergothioneine) via reverse phase liquid chromatography/mass spectrometry

次要结局

未报告次要终点

研究者

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

Wayne Campbell

Principal Investigator

Purdue University

研究点 (2)

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