Protein Digestibility of Whey and Zein.

NCT04207372 | Completed

• 1 other identifier: NL63446.081.17
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Biological Availability

Keywords

Digestibility; Whey; Zein; Protein; Ileostomates

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Whey protein isolate

EXPERIMENTAL

Dietary Supplement: whey protein isolate

Zein

EXPERIMENTAL

Dietary Supplement: Zein

Protein-free

PLACEBO COMPARATOR

Other: protein-free

Interventions

whey protein isolate DIETARY_SUPPLEMENT

whey protein isolate

Whey protein isolate

Zein DIETARY_SUPPLEMENT

zein protein

Zein

protein-free OTHER

protein free

Protein-free

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Massey University: collaborator
• Global Dairy Platform Incorporated: collaborator

Study Sites (1)

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36809852 DERIVED

MeSH Terms

Interventions

Zein

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Allocation of different proteins(or no protein) is blinded from participant.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Intervention study with 6 test days, testing 3 meals each twice

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 20, 2019
• Study Start: May 4, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

NL (1)