How spicy compounds affect blood flow in the feet

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study applying three topical TRP-activating compounds (cinnamaldehyde, allyl isothiocyanate, and capsaicin) to the skin of the feet in healthy volunteers. Vascular responses will be measured over time and across multiple doses, and the study will test reproducibility between the left and right foot and between study periods. Eligible participants are healthy white adults 18–45 years old, non-smokers, with BMI between 18 and 30 kg/m². The work is conducted at a single center using non-invasive measurements to characterize time course, dose-response, and inter-period variability of the skin blood flow response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is a white male or female ≥18 and ≤45 years of age
2. Subject is a non-smoker for at least 6 months prior to the start of the study
3. Subject has a body mass index (BMI) between 18-30 kg/m²
4. Subject is judged to be in good general health on the basis of medical history, physical examination and vital signs
5. Subject understands the procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria:

1. Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study
2. Subject has a history of significant severe (drug) allergies
3. Subject is a female who is pregnant, breast-feeding or intends to become pregnant, or is of child-bearing potential and is not using an adequate contraceptive method
4. Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study
5. Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the feet on a regular basis which cannot be discontinued for the duration of the study
6. Subject has eczema, scleroderma, psoriasis, dermatitis or keloids, tumors, ulcers, burns, skin flaps or grafts on the volar surface of the forearm or the dorsum of the feet, or any other skin abnormality that, in the opinion of the investigator, may interfere with the study assessments
7. Subject has excessive hair growth on the volar surface of the forearms or the dorsum of the feet
8. Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg
9. Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study
10. Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of illegal drugs, or has a history of substance abuse (including alcohol)
11. Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks
12. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study

Where it's running

• Center for Clinical Pharmacology
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Heleen Marynissen
• Email: heleen.marynissen@uzleuven.be
• Phone: +3216347014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.