Protein FermentationPROFUNNCT06161155
Protein Fermentation Unraveled (PROFUN) - Exploring the Relationship Between Digestibility and Metabolite Production
A study testing Protein digestibility in people with Protein Fermentation, run by Wageningen University at 1 site in Netherlands.
Trial summary
Background of the study: Protein intake is often higher than recommended in Western countries. This leads to increased amounts of protein flowing into the large intestine. Next to increased dietary protein intake, protein digestibility, and endogenous protein losses also affect the amount of protein entering the large… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Protein Fermentation
- What is being tested?
- Protein digestibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2023to 7 Feb 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and females
- Age between 16 years or older
- BMI between 18.5-30 kg/m2
- Normal bowel movement: at least one defecation per 48 hours
- Suitable veins for insertion of cannula
Who cannot join
- Having a current or past medical history or surgical events that may either put the subject as risk because of participation in the study, or influence the results of the study, including, a swallowing disorder, gastrointestinal or liver or endocrine or renal or cardiovascular disease, any other chronic disease, partial bowel resection, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants; as determined by the medical supervisor;
- Use of any medications in the week before the study that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA), as determined by medical supervisor;
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Swallowing disorders; Among others: dysphagia, any oropharyngeal or oesophageal stricture, functional abnormality, or anxiety disorders related to swallowing disorders;
- Severe dysphagia to food or pills;
- Suspected or known strictures, fistulas, or physiological/mechanical GI obstruction;
Show all 24Show fewer
- Previous GI abdominal surgery; Except: uncomplicated appendectomy, and/or laparoscopic cholecystectomy;
- Pregnancy, recent childbirth in last 6 months, or actively trying to get pregnant;
- Planned MRI procedure during the study;
- Pacemakers, defibrillator, infusion pump, or other implanted electromedical devices;
- Suffering >2 times per week from: nausea / vomiting / decreased appetite / abdominal pain / high blood pressure / headaches, shakiness, and weakness / fever / diarrhea / constipation;
- Unwilling to undergo an X-ray examination and/or ultrasound (in case sensorcapsule exit cannot be confirmed);
- Working in a professional healthcare facility (e.g. hospital, dental office, emergency room), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the study;
- Having an allergy or intolerance towards compounds in the prescribed foods (e.g. gluten, lactose, fish, peanuts, soy, nuts);
- Following a vegetarian or vegan diet;
- Use of prebiotic supplements or probiotics for 3 months before the start of the study;
- Use of antibiotics within 2 months of starting the study or planned during the study;
- Excessive alcohol consumption (alcohol: <21 consumptions/week for men, and <14 consumptions/week for women);
- Use of soft drugs within 1 month of starting the study or during the study;
- Use of hard drugs;
- Hemoglobin levels <8.5 mmol/L for men and <7.5 mmol/L for women;
- Participation in another biomedical study;
- Not having a GP;
- Being an employee of Wageningen University, Division of Human Nutrition and Health.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6708 WE
About this study
Official title: The PROFUN Study: Protein Fermentation Unraveled - Exploring the Relationship Between Digestibility and Metabolite Production.
Background of the study:
Protein intake is often higher than recommended in Western countries. This leads to increased amounts of protein flowing into the large intestine. Next to increased dietary protein intake, protein digestibility, and endogenous protein losses also affect the amount of protein entering the large intestine. However, these aspects have barely been studied, especially in humans. The large intestine is home to the largest bacterial ecosystem of the body. During the fermentation of protein by these bacteria (microbiota), metabolites are produced such as ammonia, branched-chain fatty acids, biogenic amines, phenolic compounds, indoles, and N-nitroso compounds. There is evidence that some of these metabolites could be harmful for gut epithelia, gastrointestinal health, and health in general after they enter blood circulation. In general, doing measurements inside the gastrointestinal tract is invasive. During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine, but also in situ using the GISMO GEN1 ingestible. This ingestible contains sensors to measure pH, ammonium, temperature, and redox potential.
Read more
Objective of the study:
The primary objectives of this study are:
- To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable).
- To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects, measured by ammonia concentrations.
Study design:
The study is divided into 2 phases. In phase 1, preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions. An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System, the study will continue with phase 2.
Phase 2 is a randomized cross-over controlled feeding trial. Two diets will be used: one diet containing a high digestible protein source, and the other diet containing a low digestible protein source. Each diet will be given for 7 days, with a wash-out period in between. Measurements done during the dietary interventions will be compared to the other diet, and to the baseline measurements.
Study population:
15 healthy male or female volunteers, age 16 or older, BMI 18.5-30.
Intervention:
A high digestible protein diet (30 g/d whey protein) and a low digestible protein diet (30 g/d bovine plasma protein).
Primary study parameters/outcome of the study:
Ammonia as biomarker for protein fermentation, measured in feces and urine and in situ by the GISMO GEN1 ingestible.
Also, ingestible transit time, data coverage, participant experience, and serious adverse events.
Secundary study parameters/outcome of the study (if applicable):
Secondary study parameters include other protein fermentation related metabolites measured in feces, urine and blood; microbiome composition; transit time; absorption kinetics.
- Conditions
- Protein Fermentation
- Being tested
- Protein digestibility
- Keywords
- metabolites, dietary protein, digestibility, ingestible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein digestibilityCombination product
Two protein sources differing in digestiblity will be used in the dietary intervention to create a difference in protein flow into the large intestine, resulting in different levels of protein fermentation.
Participants will swallow an ingestible that senses biomarkers related to protein fermentation.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein then bovine plasma protein | Active comparator | During the first dietary intervention, the diet is supplemented with whey protein isolate. During the second dietary intervention, the diet is supplemented with bovine plasma protein. Receives: Combination Product: Protein digestibility |
| Bovine plasma protein then whey protein | Active comparator | During the first dietary intervention, the diet is supplemented with bovine plasma protein. During the second dietary intervention, the diet is supplemented with whey protein isolate. Receives: Combination Product: Protein digestibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
GISMO GEN1 System feasibility
Ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable)
Measured: 3 times approximately 3 days during the trial, within a time frame of 2.5 months
Ammonia
Ammonia will be measured in feces, urine, and throughout the gastrointestinal tract using the GISMO GEN1 System.
Measured: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Secondary outcomes (5)
Fermentation related metabolites
Feces, urine, and the GISMO GEN1 ingestible will be used to analyze a range of protein fermentation related metabolites.
Measured: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
pH
pH in feces and measured using the GISMO GEN1 ingestible.
Measured: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Microbiome composition
Microbiome composition in feces
Measured: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Transit time
Transit time measured using the blue dye method, the insoluble marker acid-insoluble-ash, breath analysis, and the GISMO GEN1 ingestible.
Measured: 5 times during the trial (1 times during baseline measurements, twice during dietary intervention 1, twice during dietary intervention 2), within a time frame of 2.5 months
Absorption kinetics
Amino acid absorption and gut hormones
Measured: 2 times during the trial (dietary intervention 1, dietary intervention 2), within a time frame of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start21 Nov 2023
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
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 Protein FermentationStudies 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
- After baseline measurements for all participants without dietery intervention, participants will follow a dietary intervention for 7 days followed by a 7-day wash-out period and another 7-day dietary intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting IMEC-NL
- Responsible party
- Principal investigator, Guido Hooiveld, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161155
- Sponsor's protocol ID
- NL84483.091.23
- Acronym
- PROFUN
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Minderhoud R, Capuano E, de Vries S, Even A, Anesi A, Hooiveld G. Protein fermentation biomarkers in plasma and urine differ between bovine plasma protein and whey protein isolate in a randomized fully controlled dietary intervention. Am J Clin Nutr. 2026 Aug 28:101491. doi: 10.1016/j.ajcnut.2026.101491. Online ahead of print.
PubMed 42665052
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROFUN Study: Protein Fermentation Unraveled - Exploring the Relationship Between Digestibility and Metabolite Production.
- ClinicalTrials.gov ID
- NCT06161155
- Acronym / sponsor ID
- PROFUN / NL84483.091.23
- Conditions
- Protein Fermentation
- Keywords
- metabolites, dietary protein, digestibility, ingestible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Stichting IMEC-NL
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 7 Dec 2023 (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.
Background of the study:
Protein intake is often higher than recommended in Western countries. This leads to increased amounts of protein flowing into the large intestine. Next to increased dietary protein intake, protein digestibility, and endogenous protein losses also affect the amount of protein entering the large intestine. However, these aspects have barely been studied, especially in humans. The large intestine is home to the largest bacterial ecosystem of the body. During the fermentation of protein by these bacteria (microbiota), metabolites are produced such as ammonia, branched-chain fatty acids, biogenic amines, phenolic compounds, indoles, and N-nitroso compounds. There is evidence that some of these metabolites could be harmful for gut epithelia, gastrointestinal health, and health in general after they enter blood circulation. In general, doing measurements inside the gastrointestinal tract is invasive. During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine, but also in situ using the GISMO GEN1 ingestible. This ingestible contains sensors to measure pH, ammonium, temperature, and redox potential.
Objective of the study:
The primary objectives of this study are:
- To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable).
- To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects, measured by ammonia concentrations.
Study design:
The study is divided into 2 phases. In phase 1, preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions. An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System, the study will continue with phase 2.
Phase 2 is a randomized cross-over controlled feeding trial. Two diets will be used: one diet containing a high digestible protein source, and the other diet containing a low digestible protein source. Each diet will be given for 7 days, with a wash-out period in between. Measurements done during the dietary interventions will be compared to the other diet, and to the baseline measurements.
Study population:
15 healthy male or female volunteers, age 16 or older, BMI 18.5-30.
Intervention:
A high digestible protein diet (30 g/d whey protein) and a low digestible protein diet (30 g/d bovine plasma protein).
Primary study parameters/outcome of the study:
Ammonia as biomarker for protein fermentation, measured in feces and urine and in situ by the GISMO GEN1 ingestible.
Also, ingestible transit time, data coverage, participant experience, and serious adverse events.
Secundary study parameters/outcome of the study (if applicable):
Secondary study parameters include other protein fermentation related metabolites measured in feces, urine and blood; microbiome composition; transit time; absorption kinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After baseline measurements for all participants without dietery intervention, participants will follow a dietary intervention for 7 days followed by a 7-day wash-out period and another 7-day dietary intervention.
| Arm | Type | Receives |
|---|---|---|
| Whey protein then bovine plasma protein | Active comparator | Combination Product: Protein digestibilityDuring the first dietary intervention, the diet is supplemented with whey protein isolate. During the second dietary intervention, the diet is supplemented with bovine plasma protein. |
| Bovine plasma protein then whey protein | Active comparator | Combination Product: Protein digestibilityDuring the first dietary intervention, the diet is supplemented with bovine plasma protein. During the second dietary intervention, the diet is supplemented with whey protein isolate. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females
- Age between 16 years or older
- BMI between 18.5-30 kg/m2
- Normal bowel movement: at least one defecation per 48 hours
- Suitable veins for insertion of cannula
Key exclusion criteria (24 listed)
- Having a current or past medical history or surgical events that may either put the subject as risk because of participation in the study, or influence the results of the study, including, a swallowing disorder, gastrointestinal or liver or endocrine or renal or cardiovascular disease, any other chronic disease, partial bowel resection, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants; as determined by the medical supervisor;
- Use of any medications in the week before the study that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA), as determined by medical supervisor;
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Swallowing disorders; Among others: dysphagia, any oropharyngeal or oesophageal stricture, functional abnormality, or anxiety disorders related to swallowing disorders;
- Severe dysphagia to food or pills;
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 |
|---|---|---|
| Protein digestibilityTwo protein sources differing in digestiblity will be used in the dietary intervention to create a difference in protein flow into the large intestine, resulting in different levels of protein fermentation. Participants will swallow an ingestible that senses biomarkers related to protein fermentation. | Combination product | Bovine plasma protein then whey protein, Whey protein then bovine plasma protein |
Primary outcome
GISMO GEN1 System feasibility
Time frame: 3 times approximately 3 days during the trial, within a time frame of 2.5 months
Ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable)
Ammonia
Time frame: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Ammonia will be measured in feces, urine, and throughout the gastrointestinal tract using the GISMO GEN1 System.
5 secondary outcomes
Fermentation related metabolites
Time frame: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
pH
Time frame: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Microbiome composition
Time frame: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Transit time
Time frame: 5 times during the trial (1 times during baseline measurements, twice during dietary intervention 1, twice during dietary intervention 2), within a time frame of 2.5 months
Absorption kinetics
Time frame: 2 times during the trial (dietary intervention 1, dietary intervention 2), within a time frame of 3 weeks
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 28 Mar 2024.
- Derived from this study: PubMed 42665052Minderhoud R, Capuano E, de Vries S, Even A, Anesi A, Hooiveld G. Protein fermentation biomarkers in plasma and urine differ between bovine plasma protein and whey protein isolate in a randomized fully controlled dietary intervention. Am J Clin Nutr. 2026 Aug 28:101491. doi: 10.1016/j.ajcnut.2026.101491. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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 Protein digestibility in people with Protein Fermentation, 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 24 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 28 Mar 2024. 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?
GISMO GEN1 System feasibility (time frame: 3 times approximately 3 days during the trial, within a time frame of 2.5 months). 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?
On the ClinicalTrials.gov record for NCT06161155, 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 28 Mar 2024.