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临床试验/NCT03744221
NCT03744221已完成不适用

Health Effects of Sustainable Future Proteins

Wageningen University and Research2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年11月5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
36
试验地点
2
主要终点
Change in gut permeability for total cohort

研究概览

简要总结

In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The study is a double blind, randomised, cross-over, short-term trial in which 36 healthy study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions. The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.

详细描述

In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The objective is to assess the degree of digestibility and protection of the epithelial barrier of two alternative protein concentrates from corn and bovine plasma and of the commonly consumed benchmark protein whey. These outcomes will also be used to evaluate how predictive the in vitro-measurements have been for the obtained in vivo-effects. Secondary objectives are to assess the impact on other markers of gastrointestinal health, metabolic health, vascular health and satiating properties. Study design: The study is a double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar/acetylsalicylic acid test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. All measurements will be conducted after an overnight fast and a standardised evening meal prior to the study days. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions.

Study population: healthy study subjects, between 35-70y, BMI 18 - 30kg/m2, both males and females.

Intervention (if applicable): Three intervention arms of one week; a bovine plasma protein intervention, a corn protein intervention and a whey protein comparator intervention. Study subjects will receive 40 grams of protein per day during the intervention in two 20 g doses.

Main study parameters/endpoints: The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Proteins will be packed in non-transparent sealed sachets/jars and labeled with 'protein A/B/C'. Proteins will be flavored to mask taste

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects
  • Age between 35-70 y
  • BMI between 18 - 30 kg/m2

排除标准

  • Intake of medications known to change the inflammatory status (including proton pump inhibitors, anti-inflammatory medication (including NSAIDs)
  • Having a history of medical or surgical events that may significantly affect the study outcome
  • Kidney dysfunction (self-reported)
  • Gastrointestinal disorders, constipation (defecation <3 times a week) or history of gastrointestinal surgery
  • Allergies for our intervention products
  • Recent use of antibiotics (<1 month prior to day 01 of the study)
  • Not having a general practitioner
  • Mental status that is incompatible with the proper conduct of the study
  • Pregnancy or lactating
  • Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening
  • Reported slimming, medically prescribed, other (extreme) diet, or use of protein concentrates
  • Not willing to give up blood donation during the study
  • Current smokers
  • Alcohol intake > 3 glasses per day
  • Hard-drug abuse
  • Participation in other clinical trials in the past month
  • Being an employee or student of the department Consumer Science & Health group of Wageningen Food & Biobased Research

研究组 & 干预措施

Corn protein

Experimental

Corn protein powder

干预措施: Corn protein powder (Dietary Supplement)

Bovine plasma protein

Experimental

Bovine plasma protein powder

干预措施: Bovine plasma protein powder (Dietary Supplement)

control benchmark protein Whey

Active Comparator

Whey protein powder

干预措施: Whey protein powder (Dietary Supplement)

结局指标

主要结局

Change in gut permeability for total cohort

时间窗: before (Day-1) and after (Day6) the protein intervention

multi-sugar acetylsalicylic acid test

Change in blood free amino acids (e.g. Degree of digestibility) on a subset of participants

时间窗: before (Day0) each intervention, 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 the postprandial challenge test

次要结局

  • change in blood markers of intestinal health,(before (Day0) and after (Day7) the protein intervention, under fasting conditions)
  • change in VAS scores on intestinal complains(daily during the intervention from day1 until day7 of the intervention)
  • change in faecal microbiota(before (Day0) and after (Day7) the protein intervention)
  • change in faecal metabolites(before (Day0) and after (Day7) the protein intervention)

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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