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Completed

NCT Number: NCT04013607

Fiber Fermentation Kinetics Inside the Gut, and Utilization of Bacterial Metabolites

In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to determine systemic availability of SCFAs). The resulting timepoints established in this pilot study will be applied during a future human intervention study.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6708 WE, Netherlands

About this study

Background: Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC are fermented by the microbiota, hereby producing fermentation end products, mainly short chain fatty acids (SCFA) acetate, butyrate, and propionate. It is hypothesized that SCFAs mediate parts of the beneficial effects of NDC. In mice, the influx of SCFA into the host correlated strongly with improvements of markers of the metabolic syndrome, whereas concentrations of SCFA in the cecum did not. The production and influx/incorporation of SCFAs in humans will be investigated.

Study design: At day 1 the catheter will be placed. After an overnight fast at day 2, 5 subjects will consume a NDC bolus. Isotopically 13C-labelled SCFAs will be delivered in the cecum. Samples will be taken in the cecum and blood before, and continuously after dispensing the 13C-labelled SCFAs.

Study population: 5 healthy male volunteers (18-60yrs, and BMI between 18.5-30 kg/m2).

Main study parameters/endpoints: (isotopic) enrichments of SCFAs in cecum, and label incorporation in plasma metabolites such as organic acids, glucose, cholesterol, fatty acids.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males
  • Age 18-60yrs
  • BMI between 18.5 and 30 kg/m2
  • Regular bowel movement (defaecation on average once a day)
  • Signed informed consent

Exclusion criteria

  • Having a history of medical or surgical events that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease, nose/throat).
  • Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start.
  • Carrying a pacemaker or any other (implanted) medical electronic device
  • Smoker
  • Unstable body weight (weight gain or loss >5kg in the past 3 months prior to the study start)
  • Use of antibiotics within 3 months of starting the study or planned during the study
  • Use of pro- or prebiotics (e.g. galacto-oligosaccharides, fructo-oligosaccharides)
  • Constipation/infrequent bowel movement
  • Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >21 consumptions/week)
  • Participation in another biomedical study
  • Having diarrhoea within 2 months prior to the study start
  • Personnel of Wageningen University, Division of Human Nutrition, their partner and their first and second degree relatives
  • Current participation in other research from the Division of Human Nutrition
  • Not willing to have an X-ray
  • Having blood vessels that are too difficult for inserting a cannula
  • Having a hemoglobin of <8.4 mmol/L

Treatment and study plan

fructo- and galacto-oligosaccharides

Dietary Supplement

A NDC drink rich in fructo- and galacto-oligosaccharides

Primary outcomes

  1. Concentrations of SCFAs

    Time frame: Between 0 and 10 hours

    (13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS

  2. Concentrations of plasma metabolites

    Time frame: Between 0 and 10 hours

    (13-C isotopic label incorporation) in plasma metabolites by GC-MS

Secondary outcomes

  1. Concentrations of organic acids

    Time frame: Between 0 and 10 hours

    Organic acids measured in plasma and intestinal lumen by GC-MS

  2. Concentrations of carbohydrates

    Time frame: Between 0 and 10 hours

    mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen by GC-MS

  3. Concentrations of metabolites in urine

    Time frame: At baseline and after 10 hours

    bile acids, organic acids, amino acids by GC-MS

  4. Concentrations of bile acids conjugates

    Time frame: Between 0 and 10 hours

  5. Relative microbiota composition

    Time frame: Between 0 and 10 hours

    in the intestinal lumen, via 16S rRNA sequencing

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

The Study of Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2019
Registry last updated
Oct 14, 2020

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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