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

NCT04013607 | Completed

• 1 other identifier: NL69449.081.19
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolism; Dietary Fiber; Intestine

Keywords

short chain fatty acid; dietary fiber

Outcome Measures

Primary Outcomes (2)

• Concentrations of SCFAs

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

  Between 0 and 10 hours

• Concentrations of plasma metabolites

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

  Between 0 and 10 hours

Secondary Outcomes (5)

• Concentrations of organic acids

  Between 0 and 10 hours

• Concentrations of carbohydrates

  Between 0 and 10 hours

• Concentrations of metabolites in urine

  At baseline and after 10 hours

• Concentrations of bile acids conjugates

  Between 0 and 10 hours

• Relative microbiota composition

  Between 0 and 10 hours

Study Arms (1)

Fiber drink

EXPERIMENTAL

A drink high in fructo- and galacto-oligosaccharides.

Dietary Supplement: fructo- and galacto-oligosaccharides

Interventions

fructo- and galacto-oligosaccharides DIETARY_SUPPLEMENT

A NDC drink rich in fructo- and galacto-oligosaccharides

Fiber drink

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6708 WE, Netherlands

Location

Related Publications (2)

• den Besten G, Havinga R, Bleeker A, Rao S, Gerding A, van Eunen K, Groen AK, Reijngoud DJ, Bakker BM. The short-chain fatty acid uptake fluxes by mice on a guar gum supplemented diet associate with amelioration of major biomarkers of the metabolic syndrome. PLoS One. 2014 Sep 9;9(9):e107392. doi: 10.1371/journal.pone.0107392. eCollection 2014.

  PMID: 25203112 BACKGROUND

• den Besten G, Lange K, Havinga R, van Dijk TH, Gerding A, van Eunen K, Muller M, Groen AK, Hooiveld GJ, Bakker BM, Reijngoud DJ. Gut-derived short-chain fatty acids are vividly assimilated into host carbohydrates and lipids. Am J Physiol Gastrointest Liver Physiol. 2013 Dec;305(12):G900-10. doi: 10.1152/ajpgi.00265.2013. Epub 2013 Oct 17.

  PMID: 24136789 BACKGROUND

Study Officials

• Guido Hooiveld, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will consume a NDC bolus. When fermentation has started, isotopically 13C-labelled SCFAs will be delivered inside the intestine. Thereafter, production and inter-conversion of SCFAs and breakdown of fiber will be studied in luminal samples. Also blood samples will be taken to study integration of the 13C-label into various metabolic compounds.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: July 10, 2019
• Study Start: July 8, 2019
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

NL (1)