To obtain more information about the effects of capsaicin and cinnamaldehyde on the intestine, these substances will be infused directly in the duodenum. Hereafter, the permeability of the intestine, gallbladder motility and the effects on satiety…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim is to assess intestinal permeability by means of sugar
permeability test
Secondary outcome
Secondary outcomes of the study are to assess tight junction functionality in
duodenal biopsy specimens and to assess gallbladder motility and effects on
satiety.
Background summary
An altered permeability has been proposed to play an important role in the
pathogenesis of several gastrointestinal disoders, such as irritable bowel
syndrome and inflammatory bowel disease. Nutrients derived from food are able
to influence the permeability of the intestine and can therefore also affect
gastrointestinal symptoms. In this study, we will investigate the effects of
capsaicine and cinnamaldehyde, which can be found in hot peppers and cinnamon,
respectively, on gastrointestinal physiology.
Study objective
To obtain more information about the effects of capsaicin and cinnamaldehyde on
the intestine, these substances will be infused directly in the duodenum.
Hereafter, the permeability of the intestine, gallbladder motility and the
effects on satiety will be assessed.
Study design
This study is a single-blind placebo-controlled study.
Intervention
Duodenal infusion of capsaicin / cinnamaldehyde / saline (placebo)
Study burden and risks
The substances used in this study are constituents of nutritional products. The
known side-effects are nausea, burning sensation and abdominal pain. Should
these symptoms occur, they are expected to disappear within a few hours. During
vena puncture, volunteers might get a small blue spot.
The posiition of the nasoduodenal tube will be controlled by rontgen
fluoroscopy. Radiation during a fluoroscopy is equal to 10% of the annual
background radiation. Gastroduodenoscopy is used in everyday clinical practive
and is considered safe. The risk for perforation is 0.03% percent.
P.O. Box 616
6200 MD
NL
P.O. Box 616
6200 MD
NL
Listed location countries
Age
Inclusion criteria
1) Based on medical history and previous examination, no gastrointestinal complaints can be defined.
2) Age between 18 and 65 years
3) BMI between 20 and 30 kg/m2
Exclusion criteria
1) History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/¬connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/¬psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
2) Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
3) Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
4) Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
5) Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
6) Excessive alcohol consumption (>20 alcoholic consumptions per week)
7) Smoking
8) Blood donation within 3 months before the study period
9) Self-admitted HIV-positive state
Design
Recruitment
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 | NCTnummervolgt |
| CCMO | NL32963.068.10 |