In this pilot study we will investigate the acute fermentation of fructo- and galacto-oligosaccharides in the proximal colon. Moreover, we will deliver 13C-labelled SCFA via a naso-intestinal catheter to quantify the fluxes of SCFA production,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
de darm: microbiota compositie activiteit en microbiële producten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To show placement of a naso-intestinal catheter in the proximal colon, and
sampling in this intestinal region.
- (The effect of NDC on) intestine luminal NDC and its degradation products
SCFA. Also (13C label incorporation in) plasma metabolic markers such as
organic acids, amino acids, glucose, cholesterol, fatty acids and bile acids.
- To investigate if intake of dietary fiber for a couple of days will effect
in vivo acute fiber fermentation.
Secondary outcome
Intestinal lumen microbiota and activity after NDC bolus.
Background summary
Nowadays there is a strong interest in optimising human health through
manipulation of non-digestible carbohydrates (NDC). NDC can be used as
substrates by gut microbiota, which results in NDC degradation, production of
fermentation products, such as short-chain fatty acids (SCFA), and a shift in
microbiome composition and activity. 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, in contrast to the concentrations of SCFA in the cecum. Therefore,
the influx of short chain fatty acids (SCFA) into the body may be of high
importance in improving metabolism. There is a need for more studies in humans
to trace the life course of SCFA and their regulatory role in human metabolism.
To study this inner world of bacterial products in humans, we will use a
nasal-intestine catheter that can be used for delivery of components and
sampling intestinal chyme.
Study objective
In this pilot study we will investigate the acute fermentation of fructo- and
galacto-oligosaccharides in the proximal colon. Moreover, we will deliver
13C-labelled SCFA via a naso-intestinal catheter to quantify the fluxes of SCFA
production, interconversion and uptake by the host.
Study design
a small-scale, 7-day parallel feasibility trial, N=5 subjects will receive
GOS/FOS supplements (mix 1:1 ratio, 15 gram/day), and N=5 other subjects will
receive placebo supplements (isocaloric maltodextrin, 13.4 gram/day). At the
last day of the supplementation period, the catheter will be placed, and
afterwards participants stay maximum 5 hours in the hospital, to ensure
progression of the nose-intestine catheter. After an overnight fast, subjects
will visit the hospital again for measurements. A cannula for blood sampling is
placed. Subjects will consume a NDC bolus (200 mL tap water, 5 gram
fructo-oligosaccharides, 5 gram galacto-oligosaccharides, non-absorbable marker
(PEG-4000). Afterwards, they are not allowed to eat for 6.5 hours. Isotopically
13C-labelled SCFAs will be delivered in the proximal colon. Blood and
intestinal samples will be collected during the day, up to 390 minutes. Breath
samples, faeces and urine will also be collected.
Intervention
7 days FOS/GOS (15 gram/day) or 7 days maltodextrin (13.4 gram/day). NDC bolus:
200 mL tap water, 5 gram fructo-oligosaccharides, 5 gram
galacto-oligosaccharides, non-absorbable marker PEG-4000.
Study burden and risks
Subjects that participate in this study will invest approximately 15 hours. The
subjects will perceive mild discomfort during the placement of the catheter.
The radiation exposure is minimal (max. 0.05-0.10 mSv) and induces no health
risk to the healthy subjects. In case of structural complains we will council
our medical supervisor. The GOS and FOS present in the NDC bolus are
commercially available and of food-grade quality (provided by FrieslandCampina
and Sensus B.V. en AVEBE). During the test day (takes around 8 hours) we will
collect 200 mL of blood. The Hb value of each participants will be checked.
Participants will have to visit the Hospital Gelderse vallei at two occasions.
Participants will receive ¤320,- after completion of the study, they will also
receive a repayment of traveling expenditures for the visit.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
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).
* Having a history of surgical events of the gastro-intestinal tract (e.g.
bariatric surgery/gastric bypass surgery)
* Presence of swallowing disorder
* 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.
* Being lactose intolerant
* Follows a vegan diet
* 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 (less than 3 times defaecation per
week)
* Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >21 consumptions/week)
* Smoker
* Having diarrhoea within 1 month prior to the study start
* Personnel of Wageningen University, Division of Human Nutrition, their
partner and their first and second degree relatives
* Participation in another biomedical study or other research from the Division
of Human Nutrition
* Not willing to be exposed to fluoroscopy
* Is sensitive for iodinated components
* Having a hemoglobin of <8.5 mmol/L
* Having blood vessels that are too difficult for inserting a cannula
* Not having a general practitioner
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04499183 |
| CCMO | NL74418.081.20 |