Protein Digestibility of Whey and Zein. | NCT04207372

Studies
Protein Digestibility of Whey and Zein.

NCT04207372

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Dec 20, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Biological Availability

Interventions

whey protein isolate
Zein
protein-free

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2018Actual

Primary Completion Date

Jan 17, 2019Actual

Completion Date

Jan 17, 2019Actual

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Dec 19, 2019

First Posted Date

Dec 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2019

Last Update Posted Date

Dec 20, 2019Actual

Name	Class
Massey University	OTHER
Global Dairy Platform Incorporated	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Whey protein isolate	Experimental	Dietary Supplement: whey protein isolate
Zein	Experimental	Dietary Supplement: Zein
Protein-free	Placebo Comparator	Other: protein-free

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whey protein isolate	Dietary Supplement	whey protein isolate	Whey protein isolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Division of Human Nutrition, Wageningen University		Wageningen	Gelderland	6703 HA	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36809852	Derived	van der Wielen N, de Vries S, Gerrits WJ, Lammers-Jannink K, Moughan PJ, Mensink M, Hendriks W. Presence of Unabsorbed Free Amino Acids at the End of the Small Intestine Indicates the Potential for an Increase in Amino Acid Uptake in Humans and Pigs. J Nutr. 2023 Mar;153(3):673-682. doi: 10.1016/j.tjnut.2023.01.038. Epub 2023 Feb 9.

ID	Term
D055315	Prolamins
D000078522	Grain Proteins
D010940	Plant Proteins
D011506	Proteins