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Completed

NCT Number: NCT01667523

The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Based on medical history and previous examination, no gastrointestinal complaints can be defined.
  • 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.
  • BMI between 20 and 30 kg/m2

Exclusion criteria

  • 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.
  • Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
  • 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
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
  • Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
  • Excessive alcohol consumption (>20 alcoholic consumptions per week)
  • Smoking
  • Blood donation within 3 months before the study period
  • Self-admitted HIV-positive state

Treatment and study plan

Capsaicin

Dietary Supplement

1.5 mg capsaicin administered intraduodenally

Cinnamaldehyde

Dietary Supplement

70 mg per intervention administered intraduodenally

Placebo

Dietary Supplement

Physiological saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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