Wageningen University
Wageningen, Gelderland, 6708 WE, Netherlands
NCT Number: NCT04013607
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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Notify Me18 year–60 year
Male
Interventional
Not applicable
Wageningen, Gelderland, 6708 WE, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A NDC drink rich in fructo- and galacto-oligosaccharides
Time frame: Between 0 and 10 hours
(13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS
Time frame: Between 0 and 10 hours
(13-C isotopic label incorporation) in plasma metabolites by GC-MS
Time frame: Between 0 and 10 hours
Organic acids measured in plasma and intestinal lumen by GC-MS
Time frame: Between 0 and 10 hours
mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen by GC-MS
Time frame: At baseline and after 10 hours
bile acids, organic acids, amino acids by GC-MS
Time frame: Between 0 and 10 hours
Time frame: Between 0 and 10 hours
in the intestinal lumen, via 16S rRNA sequencing
Wageningen University
Other
The Study of Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
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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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