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The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Gastro, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01667523
First received: April 12, 2011
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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 Intervention
Healthy
Dietary Supplement: Capsaicin
Dietary Supplement: Cinnamaldehyde
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measurements performed in plasma


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measurements will be performed in mucosal biopsy samples

  • 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 ] [ Designated as safety issue: No ]
    Visual analogue scores will be collected from the start of the infusion until 90 minutes thereafter.

  • 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 ] [ Designated as safety issue: No ]
    Measurements will be performed on biopsy specimens

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Measurements will be performed in biopsy specimens of the duodenal mucosa


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667523

Locations
Netherlands
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Ad Masclee, MD PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Gastro, Professor Ad. AAM Masclee, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01667523     History of Changes
Other Study ID Numbers: MEC 10-3-058
Study First Received: April 12, 2011
Last Updated: August 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
capsaicin
cinnamaldehyde

Additional relevant MeSH terms:
Capsaicin
Cinnamic aldehyde
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antipruritics
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014