Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56371
Enrollment
15
Registered
2023-09-25
Start date
2023-10-10
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein fermentation

Interventions

A high digestible protein diet (30 g/d whey protein) and a low digestible protein diet (30 g/d bovine plasma protein).

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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:

Design outcomes

Primary

MeasureTime frame
Ammonia as biomarker for protein fermentation, measured in feces and urine and in situ by the GISMO GEN1 ingestible.

Secondary

MeasureTime frame
Secondary study parameters include other protein fermentation related metabolites measured in feces, urine and blood; microbiome composition; transit time; absorption kinetics.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)