An interventional study of 3-g footbath and 6-g footbath in Thermogenesis by Different-dosage Ginger Flour Footbaths, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Basic science
A study to explore whether different dosages of ginger flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.
This is a four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of ginger 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.
ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 30 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Footbath with 3g ginger flour per liter of water
Other: 3-g footbath
Footbath with 6g ginger flour per liter of water
Other: 6-g footbath
Footbath with 12g ginger flour per liter of water
Other: 12-g footbath
Footbath with warm water only
Other: Warm water footbath
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g ginger flour (3 g per l), followed by a ten-minute post-intervention rest period.
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g ginger flour (6 g per l), followed by a ten-minute post-intervention rest period.
A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g ginger flour (12 g per l), followed by a ten-minute post-intervention rest period.
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.
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.
Time frame: Immediately after the footbath, timepoint 2 (t2)
2-item warmth perception measure at the feet at t1 and 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.
Time frame: Immediately before (t1) and 10 minutes following the footbath (t3)
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.
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3).
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.
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Up to 20 minutes
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.)
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
HRV analysis: 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).
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)
HRV analysis: LF
Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis (VitaGuard® 3100 monitor, getemed, Germany).
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)
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).
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)
HRV analysis: SDNN
Standard deviation of normal to normal (NN) intervals (ms) (VitaGuard® 3100 monitor, getemed, Germany).
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)
HRV analysis: RMSSD
Root mean square of successive differences (ms) (VitaGuard® 3100 monitor, getemed, Germany).
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)
HRV analysis: pNN50
Percentage of successive NN intervals that differ from each other by more than 50 ms (%) (VitaGuard® 3100 monitor, getemed, Germany).
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 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).
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 wave analysis: Reflection Index
Reflection Index (RI, %), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany).
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 wave analysis: Perfusion Index
Perfusion Index (PI, %), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany).
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)
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)
Time frame: On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up
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)
Time frame: On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up
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)
Time frame: On the evening of the footbath, before going to sleep; on the following morning, within 15 minutes after waking up
Morning protocol: sleep quality
Self-reported sleep quality during the night following the footbaths, indicated on a seven-point rating scale (higher values represent a better outcome)
Time frame: In the morning after the footbath, within 15 minutes after waking up
Plan to share: Yes — Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Supporting information: Study protocol, Icf
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ARCIM Institute Academic Research in Complementary and Integrative Medicine