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Completed

NCT Number: NCT06161155

Protein Fermentation Unraveled (PROFUN) - 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.

Objective of the study:

The primary objectives of this study are:

1. 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). 2. 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.

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Key information

Conditions

Protein Fermentation

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, 6708 WE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein digestibility

Combination 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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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

    Feces, urine, and the GISMO GEN1 ingestible will be used to analyze a range of protein fermentation related metabolites.

  2. pH

    Time frame: 3 times during the trial (baseline measurements, dietary intervention 1, dietary intervention 2), within a time frame of 2.5 months

    pH in feces and measured using the GISMO GEN1 ingestible.

  3. 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

    Microbiome composition in feces

  4. 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

    Transit time measured using the blue dye method, the insoluble marker acid-insoluble-ash, breath analysis, and the GISMO GEN1 ingestible.

  5. Absorption kinetics

    Time frame: 2 times during the trial (dietary intervention 1, dietary intervention 2), within a time frame of 3 weeks

    Amino acid absorption and gut hormones

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Stichting IMEC-NL

Registry information

Official study title

The PROFUN Study: Protein Fermentation Unraveled - Exploring the Relationship Between Digestibility and Metabolite Production.

Acronym: PROFUN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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