Intestinal Barrier FunctionSu-ProNCT03744221
Health Effects of Sustainable Future Proteins
A study testing Corn protein powder, Bovine plasma protein powder and Whey protein powder in people with Intestinal Barrier Function and Protein Digestion Kinetics, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Barrier Function, Protein Digestion Kinetics
- What is being tested?
- Corn protein powder, Bovine plasma protein powder and Whey protein powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Nov 2018to 20 Dec 2018
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age between 35-70 y
- BMI between 18 - 30 kg/m2
Who cannot join
- Intake of medications known to change the inflammatory status (including proton pump inhibitors, anti-inflammatory medication (including NSAIDs)
- Having a history of medical or surgical events that may significantly affect the study outcome
- Kidney dysfunction (self-reported)
- Gastrointestinal disorders, constipation (defecation <3 times a week) or history of gastrointestinal surgery
- Allergies for our intervention products
- Recent use of antibiotics (<1 month prior to day 01 of the study)
Show all 17Show fewer
- Not having a general practitioner
- Mental status that is incompatible with the proper conduct of the study
- Pregnancy or lactating
- Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening
- Reported slimming, medically prescribed, other (extreme) diet, or use of protein concentrates
- Not willing to give up blood donation during the study
- Current smokers
- Alcohol intake > 3 glasses per day
- Hard-drug abuse
- Participation in other clinical trials in the past month
- Being an employee or student of the department Consumer Science \& Health group of Wageningen Food \& Biobased Research
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The study is a double blind, randomised, cross-over, short-term trial in which 36 healthy study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions. The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
Read the detailed description
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The objective is to assess the degree of digestibility and protection of the epithelial barrier of two alternative protein concentrates from corn and bovine plasma and of the commonly consumed benchmark protein whey. These outcomes will also be used to evaluate how predictive the in vitro-measurements have been for the obtained in vivo-effects. Secondary objectives are to assess the impact on other markers of gastrointestinal health, metabolic health, vascular health and satiating properties. Study design: The study is a double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar/acetylsalicylic acid test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. All measurements will be conducted after an overnight fast and a standardised evening meal prior to the study days. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions.
Study population: healthy study subjects, between 35-70y, BMI 18 - 30kg/m2, both males and females.
Intervention (if applicable): Three intervention arms of one week; a bovine plasma protein intervention, a corn protein intervention and a whey protein comparator intervention. Study subjects will receive 40 grams of protein per day during the intervention in two 20 g doses.
Main study parameters/endpoints: The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
- Being tested
- Corn protein powder, Bovine plasma protein powder, Whey protein powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn protein powderDietary supplement
Also called sustainable protein source 1
40g/d ( 2 times 20 grams per day for a period of 1 week)
Bovine plasma protein powderDietary supplement
Also called sustainable protein source 2
40g/d ( 2 times 20 grams per day for a period of 1 week)
Whey protein powderDietary supplement
Also called control protein source
40g/d ( 2 times 20 grams per day for a period of 1 week)
| Study group | Role | What they receive |
|---|---|---|
| Corn protein | Experimental | Corn protein powder Receives: Dietary Supplement: Corn protein powder |
| Bovine plasma protein | Experimental | Bovine plasma protein powder Receives: Dietary Supplement: Bovine plasma protein powder |
| control benchmark protein Whey | Active comparator | Whey protein powder Receives: Dietary Supplement: Whey protein powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut permeability for total cohort
multi-sugar acetylsalicylic acid test
Measured: before (Day-1) and after (Day6) the protein intervention
Change in blood free amino acids (e.g. Degree of digestibility) on a subset of participants
postprandial test, determine free amino acids in blood samples collected before and after the postprandial challenge test
Measured: before (Day0) each intervention, 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
Secondary outcomes (4)
change in blood markers of intestinal health,
like diamine oxidase, A1AT, citrulline, FABP-2, CRP or complement,
Measured: before (Day0) and after (Day7) the protein intervention, under fasting conditions
change in faecal microbiota
obtained from fecal samples
Measured: before (Day0) and after (Day7) the protein intervention
change in faecal metabolites
obtained from faecal samples
Measured: before (Day0) and after (Day7) the protein intervention
change in VAS scores on intestinal complains
On a scale ranging from worst-best outcome (higher scores are better)
Measured: daily during the intervention from day1 until day7 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start5 Nov 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Barrier FunctionStudies 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
- double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. 12 subjects will also receive an acute postprandial digestibility test at the start of the intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, Dr, Principal investigator, Wageningen research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744221
- Sponsor's protocol ID
- NL65835.081.18
- Acronym
- Su-Pro
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Sustainable Future Proteins
- ClinicalTrials.gov ID
- NCT03744221
- Acronym / sponsor ID
- Su-Pro / NL65835.081.18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 16 Nov 2018 (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.
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The study is a double blind, randomised, cross-over, short-term trial in which 36 healthy study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions. The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
Detailed description
In the current study the investigators aim to assess the nutritional quality and bio-functional activity of two alternative protein sources bovine plasma and corn and from the benchmark protein whey. The objective is to assess the degree of digestibility and protection of the epithelial barrier of two alternative protein concentrates from corn and bovine plasma and of the commonly consumed benchmark protein whey. These outcomes will also be used to evaluate how predictive the in vitro-measurements have been for the obtained in vivo-effects. Secondary objectives are to assess the impact on other markers of gastrointestinal health, metabolic health, vascular health and satiating properties. Study design: The study is a double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. Study subjects will visit the research facility before and after the intervention period on two separate occasions to measure gut permeability via a multi-sugar/acetylsalicylic acid test and to collect fasting blood samples and blood pressure outcomes. Faecal and saliva samples before and after each intervention will be collected. All measurements will be conducted after an overnight fast and a standardised evening meal prior to the study days. A subgroup of 12 study participants will also be subjected to a postprandial digestibility test on the first day of the interventions.
Study population: healthy study subjects, between 35-70y, BMI 18 - 30kg/m2, both males and females.
Intervention (if applicable): Three intervention arms of one week; a bovine plasma protein intervention, a corn protein intervention and a whey protein comparator intervention. Study subjects will receive 40 grams of protein per day during the intervention in two 20 g doses.
Main study parameters/endpoints: The main study parameter is to assess the protein digestion kinetics and protection of the epithelial barrier. Secondary study parameters include other markers of gastrointestinal health, metabolic health, vascular health and satiating properties.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- double blind, randomised, cross-over, short-term trial in which 36 study subject will participate. Study subjects will receive three protein interventions of 1 week with a washout period of 1 week between interventions. 12 subjects will also receive an acute postprandial digestibility test at the start of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Corn protein | Experimental | Dietary Supplement: Corn protein powderCorn protein powder |
| Bovine plasma protein | Experimental | Dietary Supplement: Bovine plasma protein powderBovine plasma protein powder |
| control benchmark protein Whey | Active comparator | Dietary Supplement: Whey protein powderWhey protein powder |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Age between 35-70 y
- BMI between 18 - 30 kg/m2
Key exclusion criteria (17 listed)
- Intake of medications known to change the inflammatory status (including proton pump inhibitors, anti-inflammatory medication (including NSAIDs)
- Having a history of medical or surgical events that may significantly affect the study outcome
- Kidney dysfunction (self-reported)
- Gastrointestinal disorders, constipation (defecation <3 times a week) or history of gastrointestinal surgery
- Allergies for our intervention products
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 |
|---|---|---|
| Corn protein powderAlso: sustainable protein source 140g/d ( 2 times 20 grams per day for a period of 1 week) | Dietary supplement | Corn protein |
| Bovine plasma protein powderAlso: sustainable protein source 240g/d ( 2 times 20 grams per day for a period of 1 week) | Dietary supplement | Bovine plasma protein |
| Whey protein powderAlso: control protein source40g/d ( 2 times 20 grams per day for a period of 1 week) | Dietary supplement | control benchmark protein Whey |
Primary outcome
Change in gut permeability for total cohort
Time frame: before (Day-1) and after (Day6) the protein intervention
multi-sugar acetylsalicylic acid test
Change in blood free amino acids (e.g. Degree of digestibility) on a subset of participants
Time frame: before (Day0) each intervention, 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
postprandial test, determine free amino acids in blood samples collected before and after the postprandial challenge test
4 secondary outcomes
change in blood markers of intestinal health,
Time frame: before (Day0) and after (Day7) the protein intervention, under fasting conditions
change in faecal microbiota
Time frame: before (Day0) and after (Day7) the protein intervention
change in faecal metabolites
Time frame: before (Day0) and after (Day7) the protein intervention
change in VAS scores on intestinal complains
Time frame: daily during the intervention from day1 until day7 of the intervention
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 16 Jan 2019.
- Individual participant dataSharing planned: No. will not be shared
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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.
Diederik Esser, Dr principal investigator
Wageningen research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn protein powder, Bovine plasma protein powder and Whey protein powder in people with Intestinal Barrier Function and Protein Digestion Kinetics, run by Wageningen University and Research 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 3 inclusion and 17 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 16 Jan 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. 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?
Change in gut permeability for total cohort (time frame: before (Day-1) and after (Day6) the protein intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2019.