The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability
Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Capsaicin (Dietary Supplement); Cinnamaldehyde (Dietary Supplement); Placebo (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Maastricht University Medical Center Official(s) and/or principal investigator(s): Ad Masclee, MD PhD, Principal Investigator, Affiliation: Maastricht University Medical Center
Summary
An altered permeability has been proposed to play an important role in the pathogenesis of
several gastrointestinal disorders, 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, the investigators
will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot
peppers and cinnamon, respectively, on gastrointestinal physiology.
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.
Hypothesis:
Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial
barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin
from enterochromaffin cells as determined by the multi sugar permeability test
Clinical Details
Official title: The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Primary outcome: To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability
Secondary outcome: To assess the effect of capsaicin and CA infusion on the activation of the TRP receptors as defined by the mucosal concentrations of the neuropeptides SP, CGRP and NKATo assess the effect capsaicin and CA on parameters that are known to be associated with satiety, measured by satiety hormones in blood plasma and mucosal tissue (CCK) as well as satiety scoring on a visual analogue scale To assess the effect of capsaicin and CA on serotonergic function in duodenal biopsy specimens by measuring serotonin and its metabolites by HPLC To assess the effect of capsaicin and CA on gallbladder motility by ultrasound To assess the effect of capsaicin and CA on the expression of tight junction proteins measured by immunohistochemistry and by quantitative PCR
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Based on medical history and previous examination, no gastrointestinal complaints can
be defined.
2. Age between 18 and 65 years. This study will include healthy adult subjects. Subjects
over 65 years have an increased risk for comorbidities, therefore, subjects over 65
years will not be included. Furthermore, age has an influence on the homeostasis of
the intestinal mucosa [21], which can potentially influence outcome parameters of the
study.
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
Locations and Contacts
Maastricht University Medical Center+, Maastricht, Limburg 6202 AZ, Netherlands
Additional Information
Starting date: February 2011
Last updated: August 16, 2012
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