Metabolism Clinical Trial
Official title:
The Study of Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
Verified date | October 2020 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | October 17, 2019 |
Est. primary completion date | October 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | University Medical Center Groningen |
Netherlands,
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. — View Citation
den Besten G, Lange K, Havinga R, van Dijk TH, Gerding A, van Eunen K, Müller 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentrations of SCFAs | (13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS | Between 0 and 10 hours | |
Primary | Concentrations of plasma metabolites | (13-C isotopic label incorporation) in plasma metabolites by GC-MS | Between 0 and 10 hours | |
Secondary | Concentrations of organic acids | Organic acids measured in plasma and intestinal lumen by GC-MS | Between 0 and 10 hours | |
Secondary | Concentrations of carbohydrates | mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen by GC-MS | Between 0 and 10 hours | |
Secondary | Concentrations of metabolites in urine | bile acids, organic acids, amino acids by GC-MS | At baseline and after 10 hours | |
Secondary | Concentrations of bile acids conjugates | Between 0 and 10 hours | ||
Secondary | Relative microbiota composition | in the intestinal lumen, via 16S rRNA sequencing | Between 0 and 10 hours |
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