The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability
Ključne besede
Povzetek
Datumi
Nazadnje preverjeno: | 07/31/2012 |
Prvič predloženo: | 04/11/2011 |
Predviden vpis oddan: | 08/15/2012 |
Prvič objavljeno: | 08/16/2012 |
Zadnja posodobitev oddana: | 08/15/2012 |
Zadnja posodobitev objavljena: | 08/16/2012 |
Dejanski datum začetka študija: | 01/31/2011 |
Predvideni datum primarnega zaključka: | 05/31/2011 |
Predvideni datum zaključka študije: | 11/30/2011 |
Stanje ali bolezen
Intervencija / zdravljenje
Dietary Supplement: Capsaicin
Dietary Supplement: Cinnamaldehyde
Dietary Supplement: Placebo
Faza
Skupine rok
Roka | Intervencija / zdravljenje |
---|---|
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 |
Merila upravičenosti
Starost, primerna za študij | 18 Years Za 18 Years |
Spol, upravičen do študija | All |
Sprejema zdrave prostovoljce | Da |
Merila | 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 |
Izid
Primarni izidni ukrepi
1. To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability [Measured at start and end of infusion (30 min), on each of the 3 test days]
Ukrepi sekundarnega rezultata
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 [1 day]
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 [1 day]
3. 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]
4. 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]
5. To assess the effect of capsaicin and CA on the expression of tight junction proteins measured by immunohistochemistry and by quantitative PCR [1 day]