Protein Digestibility of Whey and Zein.

Biological Availability Clinical Trial

Official title:

Determination of Protein Digestibility of Whey and Zein in Ileostomates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207372
• Other study ID #: NL63446.081.17
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: January 17, 2019

Study information

• Verified date: December 2019
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Biological Availability

Intervention

Dietary Supplement:
• whey protein isolate
whey protein isolate
• Zein
zein protein

Other:
• protein-free
protein free

Locations

Country	Name	City	State
Netherlands	Division of Human Nutrition, Wageningen University	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Global Dairy Platform Incorporated, Massey University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ileal amino acid digestibility of Zein and Whey Protein Isolate	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