Clinical trial NCT04321720: Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers
Official title: Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermogenesis by Different-dosage Mustard Flour Footbaths
Keywords: Mustard flour footbaths
Dose-response relationship
Thermogenesis
Infrared thermography
Heart rate variability
Healthy volunteers
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2020-03-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to explore whether different dosages of mustard flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

Detailed description: This is a blinded, four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of mustard flour in healthy volunteers, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.

Eligibility criteria: Inclusion Criteria:

* Written informed consent;
* Age between 18 and 55 years

Exclusion Criteria:

* Chronic skin lesions at the lower legs or feet
* Varicose veins grade 3 and grade 4 (Marshall stage classification)
* Chronic venous insufficiency
* Known intolerance or hypersensitivity to mustard preparations
* Cardiac arrhythmia
* Cardiac pacemaker
* Asthma bronchiale
* Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
* Pregnancy
* Insufficient knowledge of the german language

Primary outcomes:
measure: 2-item warmth perception measure at the feet after the footbath
timeFrame: Immediately after the footbath, timepoint 2 (t2)
Secondary outcomes:
measure: 2-item warmth perception measure at the feet at time point 1 (t1) and time point 3 (t3)
timeFrame: Immediately before (time point 1, t1) and 10 minutes following the footbath (time point 3, t3).
measure: 2-item warmth perception measure at the hands at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3).
measure: 2-item warmth perception measure at the head at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
measure: 1-item overall warmth perception measure at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
measure: Warmth perception and skin stimulus at the feet during the footbath
timeFrame: Up to 20 minutes
measure: Well-being at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3) (length of footbath is up to 20 minutes)
measure: Skin surface temperature at the feet at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
measure: Skin surface temperature at the lower legs at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
measure: Skin surface temperature at the hands at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
measure: Skin surface temperature in the face at t1, t2 and t3
timeFrame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3) (length of footbath is up to 20 minutes)
measure: Heart rate variability (HRV) analysis: HF
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: HRV analysis: LF
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: HRV analysis: LF/HF ratio
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: HRV analysis: SDNN
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: HRV analysis: RMSSD
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: HRV analysis: pNN50
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: Pulse wave analysis: Pulse Transit Time
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: Pulse wave analysis: Reflection Index
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: Pulse wave analysis: Perfusion Index
timeFrame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
measure: Evening morning protocol: perception of warmth and stimulus at the feet
timeFrame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
measure: Evening morning protocol: skin condition
timeFrame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
measure: Evening morning protocol: general well-being
timeFrame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
measure: Morning protocol: sleep quality: seven-point rating scale
timeFrame: In the morning after the footbath, within 15 minutes after waking up
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute Academic Research in Complementary and Integrative Medicine
name: Jan Vagedes, MD
role: PRINCIPAL_INVESTIGATOR
References: