Protein Digestibility of Whey and Zein.

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT04207372

Collaborator

Massey University (Other), Global Dairy Platform Incorporated (Other)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Biological Availability	Dietary Supplement: whey protein isolate Dietary Supplement: Zein Other: protein-free	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Intervention study with 6 test days, testing 3 meals each twiceIntervention study with 6 test days, testing 3 meals each twice

Masking:

Single (Participant)

Masking Description:

Allocation of different proteins(or no protein) is blinded from participant.

Primary Purpose:

Basic Science

Official Title:

Determination of Protein Digestibility of Whey and Zein in Ileostomates

Actual Study Start Date :

May 4, 2018

Actual Primary Completion Date :

Jan 17, 2019

Actual Study Completion Date :

Jan 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whey protein isolate	Dietary Supplement: whey protein isolate whey protein isolate
Experimental: Zein	Dietary Supplement: Zein zein protein
Placebo Comparator: Protein-free	Other: protein-free protein free

Arm

Intervention/Treatment

Experimental: Whey protein isolate

Dietary Supplement: whey protein isolate

whey protein isolate

Experimental: Zein

Dietary Supplement: Zein

zein protein

Placebo Comparator: Protein-free

Other: protein-free

protein free

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Human Nutrition, Wageningen University	Wageningen	Gelderland	Netherlands	6703 HA

Sponsors and Collaborators

Wageningen University
Massey University
Global Dairy Platform Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Geleijnse, Prof. Dr., Wageningen University

ClinicalTrials.gov Identifier:

NCT04207372

Other Study ID Numbers:

NL63446.081.17

First Posted:

Dec 20, 2019

Last Update Posted:

Dec 20, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Geleijnse, Prof. Dr., Wageningen University

Study Results

No Results Posted as of Dec 20, 2019