Status:
COMPLETED
Protein Fermentation Unraveled (PROFUN) - Exploring the Relationship Between Digestibility and Metabolite Production
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Stichting IMEC-NL
Conditions:
Protein Fermentation
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06161155
Start Date
November 21 2023
End Date
February 7 2024
Last Update
March 28 2024
Active Locations (1)
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1
Wageningen University & Research
Wageningen, Gelderland, Netherlands, 6708 WE