- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04321720
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers
September 18, 2020 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
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Filderstadt, Baden-Württemberg, Germany, 70794
- Arcim Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3-g footbath
Footbath with 3g mustard flour per liter of water
|
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.
|
Experimental: 6-g footbath
Footbath with 6g mustard flour per liter of water
|
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.
|
Experimental: 12-g footbath
Footbath with 12g mustard flour per liter of water
|
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.
|
Placebo Comparator: Warm water footbath
Footbath with warm water only
|
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-item warmth perception measure at the feet after the footbath
Time Frame: Immediately after the footbath, timepoint 2 (t2)
|
Self-reported warmth perception at both feet, assessed with the "Herdecke warmth perception questionnaire" immediately after the footbath (t2).
Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
|
Immediately after the footbath, timepoint 2 (t2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-item warmth perception measure at the feet at time point 1 (t1) and time point 3 (t3)
Time Frame: Immediately before (time point 1, t1) and 10 minutes following the footbath (time point 3, t3).
|
Self-reported warmth perception at both feet, assessed with the "Herdecke warmth perception questionnaire" immediately before (t1) and 10 minutes following the footbath (t3).
Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
|
Immediately before (time point 1, t1) and 10 minutes following the footbath (time point 3, t3).
|
2-item warmth perception measure at the hands at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3).
|
Self-reported warmth perception at both hands, assessed with the "Herdecke warmth perception questionnaire" immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).
Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3).
|
2-item warmth perception measure at the head at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Self-reported warmth perception at the head, assessed with the "Herdecke warmth perception questionnaire" immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).
Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
1-item overall warmth perception measure at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Self-reported overall warmth perception, assessed with the "Herdecke warmth perception questionnaire" immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).
The item is scored 0-4 (0 = cold; 4 = hot).
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Warmth perception and skin stimulus at the feet during the footbath
Time Frame: Up to 20 minutes
|
Self-reported perception of warmth and skin stimulus during the footbath, assessed with a dynamic warmth and skin stimulus visual analog scale (VAS), applied once per minute (0 = cold/no stimulus; 10 = very hot/very strong stimulus).
|
Up to 20 minutes
|
Well-being at t1, t2 and t3
Time Frame: 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)
|
Self-reported well-being, assessed with the "Basler Befindlichkeits-Skala" (Basel Mood Questionnaire, BBS) immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).
(BBS: 16 items; 7-point rating scale; higher values represent a better outcome.)
|
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)
|
Skin surface temperature at the feet at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
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Skin surface temperature (°C) at both feet, measured with high-resolution infrared thermography immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Skin surface temperature at the lower legs at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Skin surface temperature (°C) at both lower legs, measured with high-resolution infrared thermography immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Skin surface temperature at the hands at t1, t2 and t3
Time Frame: Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Skin surface temperature (°C) at both hands, measured with high-resolution infrared thermography immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
|
Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)
|
Skin surface temperature in the face at t1, t2 and t3
Time Frame: 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)
|
Skin surface temperature (°C) in the face, measured with high-resolution infrared thermography immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
|
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)
|
Heart rate variability (HRV) analysis: HF
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
HF: High frequency power band (0.15-0.40 Hz) (ms2) from frequency domain analysis, obtained from ECG recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
HRV analysis: LF
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
LF: Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
HRV analysis: LF/HF ratio
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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LF/HF ratio = ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz) (VitaGuard® 3100 monitor, getemed, Germany)
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Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
HRV analysis: SDNN
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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SDNN: Standard deviation of normal to normal (NN) intervals (ms) (VitaGuard® 3100 monitor, getemed, Germany)
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Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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HRV analysis: RMSSD
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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RMSSD: Root mean square of successive differences (ms) (VitaGuard® 3100 monitor, getemed, Germany)
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Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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HRV analysis: pNN50
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
pNN50: Percentage of successive NN intervals that differ from each other by more than 50 ms (%) (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Pulse wave analysis: Pulse Transit Time
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Pulse Transit Time (PTT, ms), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Pulse wave analysis: Reflection Index
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Reflection Index (RI, %, percent), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
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Pulse wave analysis: Perfusion Index
Time Frame: Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Perfusion Index (PI, %, percent), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany)
|
Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period)
|
Evening morning protocol: perception of warmth and stimulus at the feet
Time Frame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Self-reported lasting effects of the footbaths at the feet, indicated on a seven-point rating scale (higher values represent a better outcome)
|
After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Evening morning protocol: skin condition
Time Frame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Self-reported lasting effects of the footbaths on skin condition, indicated on a seven-point rating scale (higher values represent a better outcome)
|
After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Evening morning protocol: general well-being
Time Frame: After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Self-reported lasting effects of the footbaths on general well-being, indicated on a seven-point rating scale (higher values represent a better outcome)
|
After footbath in the evening, before going to sleep; on the following morning, within 15 minutes after waking up
|
Morning protocol: sleep quality: seven-point rating scale
Time Frame: In the morning after the footbath, within 15 minutes after waking up
|
Self-reported sleep quality during the night following the footbaths, indicated on a seven-point rating scale (higher values represent a better outcome)
|
In the morning after the footbath, within 15 minutes after waking up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jan Vagedes, MD, ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2020
Primary Completion (Actual)
August 25, 2020
Study Completion (Actual)
August 26, 2020
Study Registration Dates
First Submitted
March 17, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWI_12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
IPD Sharing Time Frame
The data will be made available upon publication for a duration of three months.
IPD Sharing Access Criteria
The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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