Protein Digestibility of Whey and Zein.

December 19, 2019 updated by: Geleijnse, Wageningen University

Determination of Protein Digestibility of Whey and Zein in Ileostomates

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6703 HA
        • Division of Human Nutrition, Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey protein isolate
whey protein isolate
Experimental: Zein
zein protein
Placebo Comparator: Protein-free
protein free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 hours per day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2018

Primary Completion (Actual)

January 17, 2019

Study Completion (Actual)

January 17, 2019

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NL63446.081.17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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