Thermogenesis by Different-dosage Mustard Flour Footbaths Clinical Trial
Official title:
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design
| NCT number | NCT04321720 |
| Other study ID # | SWI_12 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 20, 2020 |
| Est. completion date | August 26, 2020 |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | August 26, 2020 |
| Est. primary completion date | August 25, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Arcim Institute | Filderstadt | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| ARCIM Institute Academic Research in Complementary and Integrative Medicine | University Hospital Tuebingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 2-item warmth perception measure at the feet after the footbath | 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 | 2-item warmth perception measure at the feet at time point 1 (t1) and 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). | |
| Secondary | 2-item warmth perception measure at the hands at t1, t2 and 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). | |
| Secondary | 2-item warmth perception measure at the head at t1, t2 and 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) | |
| Secondary | 1-item overall warmth perception measure at t1, t2 and 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) | |
| Secondary | Warmth perception and skin stimulus at the feet during the footbath | 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 | |
| Secondary | Well-being at t1, t2 and t3 | 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) | |
| Secondary | Skin surface temperature at the feet at t1, t2 and t3 | 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) | |
| Secondary | Skin surface temperature at the lower legs at t1, t2 and 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) | |
| Secondary | Skin surface temperature at the hands at t1, t2 and 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) | |
| Secondary | Skin surface temperature in the face at t1, t2 and t3 | 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) | |
| Secondary | Heart rate variability (HRV) analysis: HF | 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) | |
| Secondary | HRV analysis: LF | 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) | |
| Secondary | HRV analysis: LF/HF ratio | 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) | Up to 40 minutes (continuous measurement from the beginning of the pre-intervention rest period to the end of the post-intervention rest-period) | |
| Secondary | HRV analysis: SDNN | SDNN: Standard deviation of normal to normal (NN) intervals (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) | |
| Secondary | HRV analysis: RMSSD | RMSSD: Root mean square of successive differences (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) | |
| Secondary | HRV analysis: pNN50 | 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) | |
| Secondary | Pulse wave analysis: Pulse Transit Time | 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) | |
| Secondary | Pulse wave analysis: Reflection Index | 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) | |
| Secondary | Pulse wave analysis: Perfusion Index | 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) | |
| Secondary | Evening morning protocol: perception of warmth and stimulus at the feet | 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 | |
| Secondary | Evening morning protocol: skin condition | 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 | |
| Secondary | Evening morning protocol: general well-being | 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 | |
| Secondary | Morning protocol: sleep quality: seven-point rating scale | 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 |