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临床试验/NCT03823222
NCT03823222已完成不适用

Proteins From Duckweed Trial

Wageningen University and Research2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年2月28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
12
试验地点
2
主要终点
Change in blood free amino acids (e.g. Degree of digestibility)

研究概览

简要总结

This study aims to study the digestibility of isolated duckweed protein. The digestibility of the isolated duckweed protein will be compared to an isolated benchmark protein whey.

Objective: The primary objective is to investigate the digestibility of isolated duckweed protein and the isolated benchmark protein whey.

Study design: The study is a cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two protein sources in randomized order with a washout period of one week. Blood will be collected via a catheter before and up-to 3 hours after protein consumption.

Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention: Study participants will receive 20 grams of isolated duckweed protein and the isolated benchmark protein whey.

Main study parameters/endpoints: The main study parameter is blood amino acids measured before and after consumption of 20 g protein.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) between 18 and 25 kg/m2
  • Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor)

排除标准

  • Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
  • History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
  • History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
  • Kidney dysfunction (self-reported)
  • Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility
  • Anaemia (Hb values <7.5 for women and <8.5 for men)
  • Reported slimming, medically prescribed, vegan/vegetarian or other extreme diets or the use of protein supplements
  • Not willing to give up blood donation during the study
  • Current smokers
  • Alcohol intake ≥4 glasses of alcoholic beverages per day
  • Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
  • Abuse of illicit drugs
  • Food allergies for products that we use in the study
  • Participation in another clinical trial at the same time
  • Being an employee of the department Consumer Science & Health group of Wageningen Food & Biobased Research

研究组 & 干预措施

Duckweed protein

Experimental

20 gram of isolated protein

干预措施: Duckweed protein (Dietary Supplement)

Whey protein

Experimental

20 gram of isolated protein

干预措施: Whey protein (Dietary Supplement)

结局指标

主要结局

Change in blood free amino acids (e.g. Degree of digestibility)

时间窗: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption

postprandial test, determine free amino acids in blood samples collected before and after a postprandial challenge test

次要结局

  • change in plasma glucose(20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption)
  • change in plasma insulin(20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption)

研究者

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

Diederik Esser

project leader clinical trials

Wageningen University and Research

研究点 (2)

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