The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability

NCT01667523 | Completed

• 1 other identifier: MEC 10-3-058
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

capsaicin; cinnamaldehyde

Outcome Measures

Primary Outcomes (1)

• To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability

  Measurements performed in plasma

  Measured at start and end of infusion (30 min), on each of the 3 test days

Secondary Outcomes (5)

• 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

  1 day

• 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

  1 day

• To assess the effect of capsaicin and CA on serotonergic function in duodenal biopsy specimens by measuring serotonin and its metabolites by HPLC

  1 day

• To assess the effect of capsaicin and CA on gallbladder motility by ultrasound

  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

  1 day

Study Arms (3)

Capsaicin

EXPERIMENTAL

Dietary Supplement: Capsaicin

Cinnamaldehyde

EXPERIMENTAL

Dietary Supplement: Cinnamaldehyde

Placebo

PLACEBO COMPARATOR

Physiological saline

Dietary Supplement: Placebo

Interventions

Capsaicin DIETARY_SUPPLEMENT

1.5 mg capsaicin administered intraduodenally

Capsaicin

Cinnamaldehyde DIETARY_SUPPLEMENT

70 mg per intervention administered intraduodenally

Cinnamaldehyde

Placebo DIETARY_SUPPLEMENT

Physiological saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26718419 DERIVED

MeSH Terms

Interventions

Capsaicin; cinnamaldehyde

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Ad Masclee, MD PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ad. AAM Masclee

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: August 17, 2012
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

NL (1)