Digestive SystemMyDiNCT04819789
Digestibility of Fermotein™
A study testing Fermotein™ dry powder porridge, Fermotein™ wet porridge and Fermotein™ modified wet porridge in people with Digestive System, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
This study aims to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn) and to assess the effects on blood glucose and insulin levels. The study has a randomized, cross-over, double blind, controlled design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System
- What is being tested?
- Fermotein™ dry powder porridge, Fermotein™ wet porridge and Fermotein™ modified wet porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Apr 2021to 20 May 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and women;
- Age between 18 and 70 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;
- 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;
- 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
About this study
This study aims to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn) and to assess the effects on blood glucose and insulin levels.
The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. 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 short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.
Read the detailed description
Mycoprotein is a protein source derived from fungi produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Their functional properties and nutrient content make them ideal to use as an ingredient for meat alternatives. Fermotein™ is such a mycoprotein type novel food source. The digestion characteristics of Fermotein™ are not known, but essential to evaluate their future potential as a sustainable protein source. Also, information on the degree of digestibility would strengthen a novel food dossier that is being constructed for this product.
The primary objective is to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn). Secondary objectives are to assess the effects on blood glucose and insulin levels.
The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. 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 short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.
- Conditions
- Digestive System
- Being tested
- Fermotein™ dry powder porridge, Fermotein™ wet porridge, Fermotein™ modified wet porridge, Mycoprotein porridge (matching control)
- Keywords
- Fermotein™, Digestibility, Protein digestion kinetics, Mycoprotein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermotein™ dry powder porridgeOther
At one out of four test days: Fermotein™ dry powder mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
Fermotein™ wet porridgeOther
At one out of four test days: Fermotein™ wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
Fermotein™ modified wet porridgeOther
At one out of four test days: Fermotein™ modified wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
Mycoprotein porridge (matching control)Other
Also called Quorn
At one out of four test days: Mycoprotein (Quorn) mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
| Study group | Role | What they receive |
|---|---|---|
| Fermotein™ dry | Experimental | Fermotein™ powder presented in the form of a porridge. Receives: Other: Fermotein™ dry powder porridge |
| Fermotein™ wet | Experimental | Fermotein™ wet presented in the form of a porridge. Receives: Other: Fermotein™ wet porridge |
| Fermotein™ modified wet | Experimental | Fermotein™ modified wet presented in the form of a porridge. Receives: Other: Fermotein™ modified wet porridge |
| Mycoprotein | Active comparator | This mycoprotein product presented in the form of a porridge. Receives: Other: Mycoprotein porridge (matching control) |
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 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 60, 75, 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 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 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 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 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.
- First posted29 Mar 2021
- Study start13 Apr 2021
- Primary completion20 May 2021
- Study completion20 May 2021
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Protein Brewery
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819789
- Sponsor's protocol ID
- NL74595.081.20
- Acronym
- MyDi
- Status last verified
- May 2021
- First submitted
- 24 Mar 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestibility of Fermotein™
- ClinicalTrials.gov ID
- NCT04819789
- Acronym / sponsor ID
- MyDi / NL74595.081.20
- Conditions
- Digestive System
- Keywords
- Fermotein™, Digestibility, Protein digestion kinetics, Mycoprotein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- The Protein Brewery
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 29 Mar 2021 (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.
This study aims to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn) and to assess the effects on blood glucose and insulin levels.
The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. 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 short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.
Detailed description
Mycoprotein is a protein source derived from fungi produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Their functional properties and nutrient content make them ideal to use as an ingredient for meat alternatives. Fermotein™ is such a mycoprotein type novel food source. The digestion characteristics of Fermotein™ are not known, but essential to evaluate their future potential as a sustainable protein source. Also, information on the degree of digestibility would strengthen a novel food dossier that is being constructed for this product.
The primary objective is to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn). Secondary objectives are to assess the effects on blood glucose and insulin levels.
The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. 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 short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fermotein™ dry | Experimental | Other: Fermotein™ dry powder porridgeFermotein™ powder presented in the form of a porridge. |
| Fermotein™ wet | Experimental | Other: Fermotein™ wet porridgeFermotein™ wet presented in the form of a porridge. |
| Fermotein™ modified wet | Experimental | Other: Fermotein™ modified wet porridgeFermotein™ modified wet presented in the form of a porridge. |
| Mycoprotein | Active comparator | Other: Mycoprotein porridge (matching control)This mycoprotein product presented in the form of a porridge. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Apparently healthy men and women;
- Age between 18 and 70 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 (17 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 |
|---|---|---|
| Fermotein™ dry powder porridgeAt one out of four test days: Fermotein™ dry powder mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load. | Other | Fermotein™ dry |
| Fermotein™ wet porridgeAt one out of four test days: Fermotein™ wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load. | Other | Fermotein™ wet |
| Fermotein™ modified wet porridgeAt one out of four test days: Fermotein™ modified wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load. | Other | Fermotein™ modified wet |
| Mycoprotein porridge (matching control)Also: QuornAt one out of four test days: Mycoprotein (Quorn) mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load. | Other | Mycoprotein |
Primary outcome
Change in degree of digestibility
Time frame: During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 60, 75, 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 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 60, 90, 120, 150, 180, 240, 300 minutes).
Change in plasma insulin levels
Time frame: During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 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 25 May 2021.
- Individual participant dataSharing planned: No
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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?
A study testing Fermotein™ dry powder porridge, Fermotein™ wet porridge and Fermotein™ modified wet porridge in people with Digestive System, 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 4 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 25 May 2021. 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 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 60, 75, 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?
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 25 May 2021.