Gastrointestinal ComplicationNCT04590768
Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)
A study testing Fermotein based meals in people with Gastrointestinal Complication, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Complication
- What is being tested?
- Fermotein based meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2020to 2 Nov 2020
- 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 (based on questionnaire)
- Age between 18 and 70 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
Who cannot join
- Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease), judged by the medical doctor
- History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- History of liver dysfunction (cirrhosis, hepatitis)
- Kidney dysfunction (self reported)
- Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
- Reported slimming or medically prescribed diet
Show all 13Show fewer
- Current smokers
- Alcohol intake over 4 glasses of alcoholic beverages per day
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
- Abuse of illicit drugs
- Having food allergies
- Participation in another clinical trial at the same time
- Being an employee of the department Consumer Science and Health group of Wageningen Food and Biobased Research
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Official title: Tolerance of Regular Meal Intake With Mycoprotein
This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Read the detailed description
Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.
The primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.
The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
- Conditions
- Gastrointestinal Complication
- Being tested
- Fermotein based meals, Matching control meals with whey protein and wheat bran
- Keywords
- Fermotein™, Gastrointestinal tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermotein based mealsOther
various meal products: bread, soup and an occasional burgers
Matching control meals with whey protein and wheat branOther
various meal products: bread, soup and an occasional burgers
| Study group | Role | What they receive |
|---|---|---|
| Fermotein™ | Experimental | daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger Receives: Other: Fermotein based meals |
| Matched control products | Active comparator | daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket. Receives: Other: Matching control meals with whey protein and wheat bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastro intestinal (GI) complaints
Determined by combining multiple outcome measures ( bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation) measured via questionnaires with Visual Analogue Scale (VAS) scores; from no complaints (minimal) to serious complaints (maximum). Higher values represent a worse outcome.
Measured: Daily, during 18 days of Fermotein™ intake and up to three days after intake.
Secondary outcomes (13)
change in blood hemoglobin
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood Fe (iron)
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ferritin
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood insulin
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood glucose
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood cholesterol (total)
under fasting conditions
Measured: before and after 18 days consumption of Fermotein™ or control product
change in blood ALAT
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ASAT
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood GGT
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood leukocyte cell counts
under fasting conditions
Measured: at baseline, and after 18 days of fermotein or control product consumption
change in blood creatinine
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood zonulin
under fasting conditions
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood pressure
systolic and diastolic bloodpressure
Measured: at baseline, and after 18 days of Fermotein™ or control product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Oct 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplicationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04590768
- Sponsor's protocol ID
- NL72349.081.19
- Status last verified
- Jan 2021
- First submitted
- 10 Sep 2020
- Last updated
- 20 Jan 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Regular Meal Intake With Mycoprotein
- ClinicalTrials.gov ID
- NCT04590768
- Acronym / sponsor ID
- NL72349.081.19
- Conditions
- Gastrointestinal Complication
- Keywords
- Fermotein™, Gastrointestinal tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- The Protein Brewery
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 19 Oct 2020 (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 impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Detailed description
Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.
The primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.
The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermotein™ | Experimental | Other: Fermotein based mealsdaily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger |
| Matched control products | Active comparator | Other: Matching control meals with whey protein and wheat brandaily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Apparently healthy men and women (based on questionnaire)
- Age between 18 and 70 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
Key exclusion criteria (13 listed)
- Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease), judged by the medical doctor
- History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- History of liver dysfunction (cirrhosis, hepatitis)
- Kidney dysfunction (self reported)
- Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
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 based mealsvarious meal products: bread, soup and an occasional burgers | Other | Fermotein™ |
| Matching control meals with whey protein and wheat branvarious meal products: bread, soup and an occasional burgers | Other | Matched control products |
Primary outcome
Change in gastro intestinal (GI) complaints
Time frame: Daily, during 18 days of Fermotein™ intake and up to three days after intake.
Determined by combining multiple outcome measures ( bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation) measured via questionnaires with Visual Analogue Scale (VAS) scores; from no complaints (minimal) to serious complaints (maximum). Higher values represent a worse outcome.
13 secondary outcomes
change in blood hemoglobin
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood Fe (iron)
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ferritin
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood insulin
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood glucose
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood cholesterol (total)
Time frame: before and after 18 days consumption of Fermotein™ or control product
change in blood ALAT
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ASAT
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood GGT
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood leukocyte cell counts
Time frame: at baseline, and after 18 days of fermotein or control product consumption
change in blood creatinine
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood zonulin
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood pressure
Time frame: at baseline, and after 18 days of Fermotein™ or control product consumption
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 Jan 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 based meals in people with Gastrointestinal Complication, 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 13 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 Jan 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 gastro intestinal (GI) complaints (time frame: Daily, during 18 days of Fermotein™ intake and up to three days after intake.). 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 20 Jan 2021.