Biological AvailabilityNCT04207372
Protein Digestibility of Whey and Zein.
A study testing whey protein isolate, Zein and protein-free in people with Biological Availability, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- whey protein isolate, Zein and protein-free
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 May 2018to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
About this study
Official title: 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.
Read the 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.
- Conditions
- Biological Availability
- Being tested
- whey protein isolate, Zein, protein-free
- Keywords
- Digestibility, Whey, Zein, Protein, Ileostomates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein isolateDietary supplement
whey protein isolate
ZeinDietary supplement
zein protein
protein-freeOther
protein free
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate | Experimental | Not described Receives: Dietary Supplement: whey protein isolate |
| Zein | Experimental | Not described Receives: Dietary Supplement: Zein |
| Protein-free | Placebo comparator | Not described Receives: Other: protein-free |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 hours per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start4 May 2018
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention study with 6 test days, testing 3 meals each twice
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Massey University, Global Dairy Platform Incorporated
- Responsible party
- Principal investigator, Geleijnse, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207372
- Sponsor's protocol ID
- NL63446.081.17
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36809852
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Protein Digestibility of Whey and Zein in Ileostomates
- ClinicalTrials.gov ID
- NCT04207372
- Acronym / sponsor ID
- NL63446.081.17
- Conditions
- Biological Availability
- Keywords
- Digestibility, Whey, Zein, Protein, Ileostomates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Massey University, Global Dairy Platform Incorporated
- Study start
- 4 May 2018 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Intervention study with 6 test days, testing 3 meals each twice
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate | Experimental | Dietary Supplement: whey protein isolate |
| Zein | Experimental | Dietary Supplement: Zein |
| Protein-free | Placebo comparator | Other: protein-free |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protein isolatewhey protein isolate | Dietary supplement | Whey protein isolate |
| Zeinzein protein | Dietary supplement | Zein |
| protein-freeprotein free | Other | Protein-free |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Derived from this study: PubMed 36809852van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein isolate, Zein and protein-free in people with Biological Availability, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ileal amino acid digestibility of Zein and Whey Protein Isolate (time frame: 9 hours per day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.