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临床试验/NCT04871971
NCT04871971已完成不适用

Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

Oxford Brookes University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9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
30
试验地点
2
主要终点
Area under the blood glucose concentration versus time curve

研究概览

简要总结

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.

详细描述

A single-blind, randomised, repeat measure, crossover design trial will be used to study the glycaemic response and insulinaemic response following consumption of five products: one reference product (50 g available carbohydrate Glucose) and four test products (50 g available carbohydrate Glucose with 10 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 20 g NUTRALYS®S85 Plus pea protein, 50 g available carbohydrate Glucose with 10 g Whey protein concentrate and 50 g available carbohydrate Glucose with 20 g Whey protein concentrate).

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
Single (Participant)

盲法说明

single-blind

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 60 years
  • Body mass index (BMI) less than 30kg/m2

排除标准

  • Pregnant or lactating
  • Fasting blood glucose value > 6.1 mmol/l
  • Any known food allergy or intolerance
  • Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
  • Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions
  • Major medical or surgical event requiring hospitalization within the preceding 3 months
  • Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution)
  • Unable to comply with experimental procedures or did not follow GR testing safety guidelines.

结局指标

主要结局

Area under the blood glucose concentration versus time curve

时间窗: 3 hours

Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule

Area under the plasma insulin concentration versus time curve

时间窗: 3 hours

Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule

Change in plasma insulin response from baseline for 3 hours

时间窗: 3 hours

Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Time of plasma insulin peak (Tmax)

时间窗: 0-3 hours

Time of plasma insulin peak after consumption of the test food

Change in blood glucose response from baseline for 3 hours

时间窗: 3 hours

Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours

Peak plasma insulin concentration (Cmax)

时间窗: 0-3 hours

Peak plasma insulin concentration (Cmax) after consumption of the test food

Time of blood glucose peak (Tmax)

时间窗: 0-3 hours

Time of blood glucose peak after consumption of the test food

Peak blood glucose concentration (Cmax)

时间窗: 0-3 hours

Peak blood glucose concentration (Cmax) after consumption of the test food

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

Dr. Sangeetha Thondre

Principal Investigator

Oxford Brookes University

研究点 (2)

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