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The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

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ClinicalTrials.gov Identifier: NCT01667523
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Gastro, Maastricht University Medical Center

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Capsaicin Dietary Supplement: Cinnamaldehyde Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Capsaicin Dietary Supplement: Capsaicin
1.5 mg capsaicin administered intraduodenally
Experimental: Cinnamaldehyde Dietary Supplement: Cinnamaldehyde
70 mg per intervention administered intraduodenally
Placebo Comparator: Placebo
Physiological saline
 Dietary Supplement: Placebo
Physiological saline


Outcome Measures
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Primary Outcome Measures :
  1. To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability [ Time Frame: Measured at start and end of infusion (30 min), on each of the 3 test days ]
    Measurements performed in plasma


Secondary Outcome Measures :
  1. 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 NKA [ Time Frame: 1 day ]
    Measurements will be performed in mucosal biopsy samples

  2. To 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 [ Time Frame: 1 day ]
    Visual analogue scores will be collected from the start of the infusion until 90 minutes thereafter.

  3. To assess the effect of capsaicin and CA on serotonergic function in duodenal biopsy specimens by measuring serotonin and its metabolites by HPLC [ Time Frame: 1 day ]
    Measurements will be performed on biopsy specimens

  4. To assess the effect of capsaicin and CA on gallbladder motility by ultrasound [ Time Frame: Measurements will be performed during the testday starting from 08.00 AM to 11.00AM ]
  5. To assess the effect of capsaicin and CA on the expression of tight junction proteins measured by immunohistochemistry and by quantitative PCR [ Time Frame: 1 day ]
    Measurements will be performed in biopsy specimens of the duodenal mucosa


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667523


Locations
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Netherlands
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
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Principal Investigator: Ad Masclee, MD PhD Maastricht University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gastro, Professor Ad. AAM Masclee, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01667523    
Other Study ID Numbers: MEC 10-3-058
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012
Keywords provided by Gastro, Maastricht University Medical Center:
capsaicin
cinnamaldehyde
Additional relevant MeSH terms:
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Cinnamic aldehyde
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antimutagenic Agents
Protective Agents