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临床试验/NCT03667963
NCT03667963已完成不适用

Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Rice Prepared in Different Ways

University of Toronto2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月29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
40
试验地点
2
主要终点
Glycemic Index (GI)

研究概览

简要总结

This study evaluates the effect of different methods of preparation (cooked and consumed hot vs cooked, cooled overnight and consumed cold) and variation in the activity of salivary amylase on the glycemic index and carbohydrate digestibility in healthy human subjects. The effect of genetic variation in small intestinal starch digesting enzymes on glycemic index and starch digestibility will also be assessed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or non-pregnant females aged 18-75 years and in good health
  • Eligible to receive income in Canada
  • Have Ontario Health Insurance Plan or equivalent medical coverage.
  • Previous donor of saliva using protocol reference number # 31093 or GIL-1670 (in which subject consents to measurement of salivary amylase activity and genetic variation in AMY1, SI and MGAM genes).
  • Salivary amylase activity in the lowest tertile (<50 U/ml) or highest tertile (>105 U/ml) of salivary amylase activity of 40 subjects previously measured.

排除标准

  • known history of AIDS, hepatitis, diabetes or a heart condition
  • Allergy to rice, canola oil or sesame oil.
  • use of medications (including, but not limited to, insulin or other antidiabetic drugs, systemic steroids, antipsychotics, protease inhibitors, antivirals, immunosuppressive agents and drugs affecting gut motility or digestion) or with any condition which might, in the opinion of Dr. Wolever, the Medical Director or GI Labs, either: 1) make participation dangerous to the participant himself (or herself) or to others, or 2) affect the results.
  • individuals who cannot or will not comply with the experimental procedures or do not follow the instructions of GI Labs staff related to the safe performance of the experimental procedures

研究组 & 干预措施

Low Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Glucose plus lactulose (Other)

Low Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Hot Rice (Other)

Low Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Cold Rice (Other)

High Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Glucose plus lactulose (Other)

High Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Hot Rice (Other)

High Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Cold Rice (Other)

Low Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Glucose (Other)

High Salivary Amylase Activity

Other

Glucose Glucose plus lactulose Hot Rice Cold Rice

干预措施: Glucose (Other)

结局指标

主要结局

Glycemic Index (GI)

时间窗: 0-2 hours

For each subject, the incremental area under the glucose response curve over 2 hours (iAUC) after each rice test meal is expressed as a percentage of the mean iAUC elicited by the 2 glucose test meals.

次要结局

  • Breath hydrogen response(0-6 hours)
  • Carbohydrate malabsorbed(0-6 hours.)
  • Glycemic response(0-2 hours)

研究者

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

Thomas Wolever

Professor

University of Toronto

研究点 (2)

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