1. To quantify the CGRP response after application of red chili pepper extract2. To find the optimal concentration of red chilli homogenate containing capsaicin for this response3. To assess day-to-day variability.
ID
Source
Brief title
Condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CGRP in saliva in pg/ml
Secondary outcome
The sensation of heat on a scale of 1-10.
Background summary
Capsaicin is derived from hot peppers of the Capsicum genus and binds to
transient receptor potential channels, such as the TRPV1 (formerly known as
vanilloid receptor type 1). Activation of the vanilloid receptors on trigeminal
nerve terminals causes the release of calcitonin gene-related peptide (CGRP, a
37 amino-acid inflammatory neuropeptide) as well as other inflammatory
mediators, also from the major salivary glands and buccal mucosa. The salivary
CGRP response after capsaicin might reflect the *activation state* of the
trigeminal nerve, innervating the salivary glands. However, quantification of
CGRP release after dermal capsaicin application is difficult. Application of
capsaicin in the oral cavity also activates trigeminal nerve endings and the
subsequent release of CGRP in saliva can be quantified in animals. In humans
there are no good reference studies yet. This, however, is useful since it
enables to study a variety of trigeminal conditions including headaches
non-invasively and prospectively.
Study objective
1. To quantify the CGRP response after application of red chili pepper extract
2. To find the optimal concentration of red chilli homogenate containing
capsaicin for this response
3. To assess day-to-day variability.
Study design
Intervention study
Intervention
The application of red chilli homogenate to the oral cavity
Study burden and risks
The burden of this study consits of the time the participants have to invest in
the study (110 min)
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 55 years
Male or female
Body mass index between 18 and 30 kg/m2
Capable and willing to give informed consent
General good health
Exclusion criteria
Any serious illness that can compromise study participation
Use of any medication (e.g., NSAIDs, other analgesics) < 48 hrs before the study
History of sensitivity to the fruits of capsicum plants (e.g. chilli peppers)
Alcohol or drug abuse
History of migraine
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41323.078.12 |