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临床试验/NCT03620812
NCT03620812已完成不适用

Influence of Rapeseed Proteins on the Postprandial Metabolic Response.

Martin-Luther-Universität Halle-Wittenberg2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月16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
20
试验地点
2
主要终点
time course of glucose level

研究概览

简要总结

The aim of the study is to investigate the effect of rapeseed proteins on the postprandial metabolic response. Therefore, study participants will receive a meal rich in fat and carbohydrates with and without rapeseed protein or with soy protein that serves as control.

详细描述

The current study is a monocentric, controlled intervention study that will be conducted as cross-over design. Three interventions are planned and participants will be invited to consume a test meal with added rapeseed protein isolate, a test meal with added soy protein isolate and a test meal without additional protein. The evening before, the subjects will receive a standardized dinner. After a 12-hour fasting overnight, a cannula will be placed. Blood samples will be taken before and after eating the test meal rich in carbohydrate and fat. The test meal consists of pasta with oily tomato sauce with either 25 g of rapeseed protein, 25 g of soy protein or no additional protein. A total of 11 blood samples will be collected over a period of 6 hours. In the meantime, the blood pressure and pulse will be measured repeatedly and information on satiety will be recorded. The interventions will be interrupted by a period of, at least, 2 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy men and women
  • age between 18 and 65 years
  • informed consent
  • body mass index between 18,5 up to 29,9 kg/m2
  • anamnesis without diagnostic findings

排除标准

  • acute or chronic diseases ((hypertension, coronary diseases, renal diseases, diabetes, alcohol abuse etc.)
  • intake of drugs (exemption: oral contraceptive)
  • pregnancy or lactation
  • food intolerance or allergies to mustard, soy, tomato, wheat
  • participation on another trial
  • blood donation - while last 2 month before the start of the study
  • extensive physical activity (competitive sports, hard physical work)
  • diet procedure

结局指标

主要结局

time course of glucose level

时间窗: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

Impact of rapeseed protein on the postprandial blood glucose level

次要结局

  • indole-3-propionate(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • Cholesterol(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • heart rate(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • systolic and diastolic blood pressures(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • minerals and blood hsCRP(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • triglycerides(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • short chain fatty acids(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • amino acids(0,15,30,45,60,90,120 and 180 min after ingestion of testmeal rich in carbohydrates and fat)
  • time course of urea level,(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • feeling of satiety by means of a questionnaire(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)
  • hormones (insulin, ghrelin, FGF23)(0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat)

研究者

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

Ulf Schlegelmilch

Study Coordinator

Martin-Luther-Universität Halle-Wittenberg

研究点 (2)

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