Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 12, 2011
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date August 17, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • 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
  • 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.
  • 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
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability
Official Title  ICMJE The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Capsaicin
    1.5 mg capsaicin administered intraduodenally
  • Dietary Supplement: Cinnamaldehyde
    70 mg per intervention administered intraduodenally
  • Dietary Supplement: Placebo
    Physiological saline
Study Arms  ICMJE
  • Experimental: Capsaicin
    Intervention: Dietary Supplement: Capsaicin
  • Experimental: Cinnamaldehyde
    Intervention: Dietary Supplement: Cinnamaldehyde
  • Placebo Comparator: Placebo
    Physiological saline
    Intervention: Dietary Supplement: Placebo
Publications * van Avesaat M, Troost FJ, Westerterp-Plantenga MS, Helyes Z, Le Roux CW, Dekker J, Masclee AA, Keszthelyi D. Capsaicin-induced satiety is associated with gastrointestinal distress but not with the release of satiety hormones. Am J Clin Nutr. 2016 Feb;103(2):305-13. doi: 10.3945/ajcn.115.123414. Epub 2015 Dec 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2012)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01667523
Other Study ID Numbers  ICMJE MEC 10-3-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gastro, Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Top Institute Food and Nutrition
Investigators  ICMJE
Principal Investigator: Ad Masclee, MD PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP