The PROFUN study: PROtein Fermentation UNraveled - Exploring the relationship between digestibility and metabolite production.

Completed

• Conditions: Protein fermentation; 10018012

• Registration Number: NL-OMON56371
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- 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

Exclusion Criteria

- 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;
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ammonia as biomarker for protein fermentation, measured in feces and urine and<br /><br>in situ by the GISMO GEN1 ingestible.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include other protein fermentation related<br /><br>metabolites measured in feces, urine and blood; microbiome composition; transit<br /><br>time; absorption kinetics. </p><br>