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Completed

NCT Number: NCT04207372

Protein Digestibility of Whey and Zein.

The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

About this study

Objective: This study aims to determine the digestibility of amino acids in two protein sources in men and women with normally functioning ileostomies.

Study design: Intervention study with 6 test days, testing 3 meals each twice. Study population: Eight men and women with normally functioning ileostomies will be recruited for the study.

Intervention: On six separate test days, subjects will receive a meal, consisting of a drink and biscuit. With this, two different protein containing meals, i.e. zein and whey, and a protein-free meal is tested; these three treatments are given at two occasions, thus in total 6 meals are tested. After consumption of the meal, subjects collect their digesta for nine hours.

Main study parameters/endpoints: Ileal amino acid digestibility of zein and whey protein isolate.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subject will not benefit from the study except for the contribution to scientific research. The risk of participating to this study is low, some gastrointestinal discomfort could occur. Subjects have to come to the research facility seven times, a screening visit of 1 hour, and 6 experimental days of 10 hours. Subjects will be financially compensated for participation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age between 18 and 60
  • Willing to eat animal protein
  • Have a well-established and normally functioning terminal ileostomy, with stomal faeces of normal physiological consistency
  • Good general health, meaning subjects should be well-recovered from the ileostomy operation, their underlying disease should be cured or in remission and they should not have any other major health problems

Exclusion criteria

  • Taken antibiotics or medication that majorly impair small intestinal digestion and absorption within eight weeks of participating in the study.
  • Have been pregnant or breastfeeding in the last 12 months, or plan to become pregnant during the study
  • Having renal impairment, coeliac disease or diabetes
  • Drug abuse
  • Alcohol consumption of >14 units per week.
  • Having an allergy or intolerance to dairy, corn products or fructose
  • Currently taking protein supplements and would not be willing to stop using these during the study
  • Being on a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study
  • Personnel of division of Human Nutrition, Wageningen University..
  • Current participation in other research from the Division of Human Nutrition
  • Not having a general practitioner

Treatment and study plan

Whey protein isolate

Dietary Supplement

whey protein isolate

Zein

Dietary Supplement

zein protein

protein-free

Other

protein free

Primary outcomes

  1. the ileal amino acid digestibility of Zein and Whey Protein Isolate

    Time frame: 9 hours per day

    ileal digesta samples are collected in the nine hours after consumption of these proteins and after consumption of a protein-free diet.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Global Dairy Platform Incorporated
  • Massey University

Registry information

Official study title

Determination of Protein Digestibility of Whey and Zein in Ileostomates

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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