The objective of this proof-of-concept study is to investigate (differences in) small intestine microbiota and postprandial glycemic responses.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
de darm: samenstelling en activiteit microbiota
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The impact of the (combination of) food product(s) on postprandial glycemic
responses and small intestine microbiota, and whether there is a relation
between differences in small intestine microbiota and glycemic responses.
Secondary outcome
The expression of genes involved in glucose uptake and metabolism in cultured
small intestine epithelial cells after exposure to luminal samples.
Background summary
Dysregulated glycemic control is a central characteristic of many chronic
metabolic diseases. Postprandial glycemic responses are highly variable between
subjects consuming the same food product, and may be even opposite between
products that contain the same amount of carbohydrates. This variability has
been linked to the highly personal fecal microbiome. Glucose is primarily
absorbed in the proximal small intestine (SI), but feces however does not
represent the SI microbiome. Studies with experimental animals have already
shown the importance of the SI microbiota for nutrient digestion and
absorption. There is a strong need to confirm this paradigm in humans. We will
apply naso-intestinal catheters to sample luminal content from the small
intestine for microbiota analysis after consumption of different food products.
Study objective
The objective of this proof-of-concept study is to investigate (differences in)
small intestine microbiota and postprandial glycemic responses.
Study design
A 6 day, proof-of-concept study with crossover design, in which N=20 subjects
will participate. Blood glucose levels will be determined by a continuous
glucose monitoring device. After a stabilization period, subjects will be
equipped with a naso-intestinal catheter, followed by consumption of a
standardized (combination of) food product(s). During 4 hrs luminal content and
plasma will be sampled. After a wash-out period of 1 day, this procedure will
be repeated with a second, different standardized (combination of) food
product(s). Breath, urine and fecal samples will also be collected.
Intervention
Consumption of 2 standardized (combination of) food product(s), together with a
non-absorbable marker (PEG-4000).
Study burden and risks
Subjects that participate in this study invest approximately 30 hrs. Subjects
The subjects may perceive mild discomfort during the placement of the catheter.
During the 2 test days, a total volume of 252 mL of blood will be
sampled.Participant will be checked for hemoglobin levels to prevent the
occurrence of anemia. Regular, commercially available food products will be
used as intervention products. Subjects will visit Hospital Gelderse Vallei
twice, and will receive ยค425, as reimbursement after completion of the study;
they will also receive a repayment of traveling expenditures for each visit.
HELIX - Stippeneng 4
Wageningen 6708WE
NL
HELIX - Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
- Males and females
- BMI equal or larger than 25 kg/m2
- Age 40-75 years
- Signed informed consent
Exclusion criteria
- Having a history of medical or surgical events that may either put the
subject at risk because of participation in the study, or influence the results
of the study, including diabetes type 1, a swallowing disorder,
gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases,
gastric bypass surgery, use of anticoagulants;
-Having dementia (e.g. Alzheimer's Disease, vascular dementia, Lewy body
dementia)
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand
disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Use of antibiotics within 2 months of starting the study or planned during
the study;
- Use of medication that could influence the study results, such as diabetes
treatment;
- Use of pro- and prebiotic supplements;
-Sensitive to medical skin adhesives;
-Having an allergy or intolerance towards compounds in the test products;
-Following a vegan diet;
-Excessive alcohol consumption (on average >21 glasses/week for men and >14
glasses/week for women);
-The use of recreational drugs;
-Currently a research subject in another clinical trial;
-Having blood vessels that are too difficult for inserting a cannula/blood
drawing;
-Having a hemoglobin level <8.5 mmol/l (men) or <7.5 mmol/l (women);
-Being a blood donor during the duration of the study;
-Not having a General Practitioner (GP);
-Being an employee of Wageningen University, division Human Nutrition and
Health.
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 |
|---|---|
| Other | clinicaltrials.gov |
| CCMO | NL78737.091.21 |