Digestive SystemBar-proNCT05426122

Degree of Digestibility of Barley Rice Proteins

A study testing Barley rice protein concentrate shake, Pea protein concentrate shake and Whey protein concentrate shake in people with Digestive System, run by Wageningen University and Research at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess the degree of digestibility of barley rice protein and compare this to another sustainable, commercially available protein concentrate (pea protein), and a benchmark whey protein, and to assess the effects on blood glucose and insulin levels. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Digestive System
What is being tested?: Barley rice protein concentrate shake, Pea protein concentrate shake and Whey protein concentrate shake
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteNetherlands
Study dates: 9 Jun 2022to 14 Jul 2022
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Apparently healthy men and women;
Age between 18 and 40 years;
Body mass index (BMI) between 18.5 and 30 kg/m2 ;
Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).

Who cannot join

Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system;
History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
Kidney dysfunction (self-reported);
Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;
Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility, this will be judged by the medical supervisor;

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Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men);
Reported slimming, medically prescribed or other extreme diets;
Use of protein supplements;
Not willing to give up blood donation during the study;
Current smokers;
Alcohol intake ≥4 glasses of alcoholic beverages per day;
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
Abuse of hard drugs;
Having food allergies and/or intolerances (e.g. for gluten);
Not having a general practitioner;
Participation in another clinical trial at the same time;
Being an employee of the department Food, Health \& Consumer Research of Wageningen Food \& Biobased Research.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG

Other trials in Netherlands

About this study

The study is a randomized, cross-over, double blind, controlled trial. Three different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. Blood will be collected via a catheter before and up-to five hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via a short questionnaire during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Read the detailed description

Barley rice protein is extracted from brewer spent grains (BSG), which is the most voluminous by-product of the brewing industry. Until now, BSG has been mainly used for animal feed or is directly discarded, which is an enormous waste of resources and causes serious environmental pollution. BSG is rich in cellulose and non-cellulosic polysaccharides, lignin, and proteins. The protein fraction of BSG contains a relatively high content of the essential amino acid, lysine, in comparison to other cereal products. Because of its high nutritional content, BSG can be applied in human food products for fortification. The digestion characteristics of barley rice protein are not known, but essential to evaluate their future potential as a sustainable protein source.

The primary objective is to estimate the degree of digestibility of barley rice protein by measuring post-prandial amino acid uptake kinetics, and compare this to pea protein and a benchmark protein (whey).

Secondary objectives are to assess the effects on blood glucose and insulin levels.

Conditions: Digestive System
Being tested: Barley rice protein concentrate shake, Pea protein concentrate shake, Whey protein concentrate shake
Keywords: Barley rice protein, Digestibility, Protein digestion kinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Barley rice protein concentrate shakeOther
At one out of three test days barley rice protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.
Pea protein concentrate shakeOther
At one out of three test days pea protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.
Whey protein concentrate shakeOther
At one out of three test days whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Study groups in NCT05426122
Study group	Role	What they receive
Barley rice protein	Experimental	Barley rice protein powder presented as a shake Receives: Other: Barley rice protein concentrate shake
Pea protein	Experimental	Pea protein powder presented as a shake Receives: Other: Pea protein concentrate shake
Whey protein	Experimental	Whey protein powder presented as a shake Receives: Other: Whey protein concentrate shake

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in degree of digestibility
In order to assess change in the degree of digestibility, we determine 19 free amino acids in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption. Blood amino acids will be determined by the laboratory of Wageningen FBR, according a valid method: AccQ-Tag ultra-derivation kit \& HPLC.
Measured: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)

Secondary outcomes (2)

Change in plasma glucose levels
Plasma glucose levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands)
Measured: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)
Change in plasma insulin levels
Plasma insulin levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands).
Measured: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 202214 Jul 2022

First posted21 Jun 2022
Study start9 Jun 2022
Primary completion14 Jul 2022
Study completion14 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Digestive SystemStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Crossover Assignment
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05426122
Sponsor's protocol ID: 6239222600
Acronym: Bar-pro
Status last verified: Jul 2022
First submitted: 15 Jun 2022
Last updated: 18 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Digestive System trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Degree of Digestibility of Barley Rice Proteins
ClinicalTrials.gov ID: NCT05426122
Acronym / sponsor ID: Bar-pro / 6239222600
Conditions: Digestive System
Keywords: Barley rice protein, Digestibility, Protein digestion kinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Wageningen University and ResearchUniversity, hospital or other
Study start: 9 Jun 2022 (actual)
Primary completion: 14 Jul 2022 (actual)
Study completion: 14 Jul 2022 (actual)
First posted: 21 Jun 2022 (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.

Detailed description

Secondary objectives are to assess the effects on blood glucose and insulin levels.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Crossover Assignment

Arm	Type	Receives
Barley rice protein	Experimental	Other: Barley rice protein concentrate shakeBarley rice protein powder presented as a shake
Pea protein	Experimental	Other: Pea protein concentrate shakePea protein powder presented as a shake
Whey protein	Experimental	Other: Whey protein concentrate shakeWhey protein powder presented as a shake

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Apparently healthy men and women;
Age between 18 and 40 years;
Body mass index (BMI) between 18.5 and 30 kg/m2 ;
Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).

Key exclusion criteria (18 listed)

Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system;
History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
Kidney dysfunction (self-reported);
Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;

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
Barley rice protein concentrate shakeAt one out of three test days barley rice protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.	Other	Barley rice protein
Pea protein concentrate shakeAt one out of three test days pea protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.	Other	Pea protein
Whey protein concentrate shakeAt one out of three test days whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.	Other	Whey protein

Primary outcome

Change in degree of digestibility
Time frame: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)
In order to assess change in the degree of digestibility, we determine 19 free amino acids in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption. Blood amino acids will be determined by the laboratory of Wageningen FBR, according a valid method: AccQ-Tag ultra-derivation kit \& HPLC.

2 secondary outcomes

Change in plasma glucose levels
Time frame: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)
Change in plasma insulin levels
Time frame: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)

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 18 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Digestive System

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
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Ulcerative Colitis, Crohn's Disease
Recruiting
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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, PhD principal investigator

Wageningen University and Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 18 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 18 Jul 2022. 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 degree of digestibility (time frame: During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)). 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 NCT05426122.

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 18 Jul 2022.