Trials Sponsors Conditions Drugs Pricing

Conditions

Protein Fermentation

Keywords

metabolitesdietary proteindigestibilityingestible

Outcome Measures

Primary Outcomes (2)

GISMO GEN1 System feasibility
Ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable)
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.
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
3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
pH
3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Microbiome composition
3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months
Transit time
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
2 times during the trial (dietary intervention 1, dietary intervention 2), within a time frame of 3 weeks

Study Arms (2)

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.

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.

Combination Product: Protein digestibility

Interventions

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.

Bovine plasma protein then whey proteinWhey protein then bovine plasma protein

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Males and females
Age between 16 years or older

Sponsors & Collaborators

Wageningen University
Otherlead
Stichting IMEC-NL
Othercollaborator

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708 WE, Netherlands

Related Publications (1)

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.
PMID: 42665052DERIVED

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: Participants are masked regarding the protein source in the dietary intervention. Participants are not masked regarding the ingestible.
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

October 19, 2023

First Posted

December 7, 2023

You may not qualify if:

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;
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;
+9 more criteria

Protein Fermentation Unraveled (PROFUN) - Exploring the Relationship Between Digestibility and Metabolite Production

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Whey protein then bovine plasma protein

Bovine plasma protein then whey protein

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Protein Fermentation Unraveled (PROFUN) - Exploring the Relationship Between Digestibility and Metabolite Production

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Whey protein then bovine plasma protein

Bovine plasma protein then whey protein

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations