Arcim Institute
Filderstadt, Baden-Wurttemberg, 70794, Germany
Completed
NCT Number: NCT04051476
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Written informed consent
- Age between 18 and 55 years
Exclusion criteria
- Chronic skin lesions at the lower legs or feet
- Known intolerance or hypersensitivity to ginger preparations
- Cardiac arrhythmia
- Cardiac pacemaker
- Asthma bronchiale
- Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
- Pregnancy
- Insufficient knowledge of the german language
Treatment and study plan
3-g footbath
OtherA 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.
6-g footbath
OtherA 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.
12-g footbath
OtherA 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.
Warm Water Footbath
OtherA 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.
Primary outcomes
-
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.
Secondary outcomes
-
2-item warmth perception measure at the feet at t1 and t3
Time frame: Immediately before (t1) and 10 minutes following the footbath (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.
-
2-item warmth perception measure at the hands at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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.
-
2-item warmth perception measure at the head at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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.
-
1-item overall warmth perception measure at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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).
-
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).
-
Well-being at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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.)
-
Skin surface temperature at the feet at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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).
-
Skin surface temperature at the lower legs at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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).
-
Skin surface temperature at the hands at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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).
-
Skin surface temperature in the face at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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).
-
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)
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).
-
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)
Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis (VitaGuard® 3100 monitor, getemed, Germany).
-
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)
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).
-
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)
Standard deviation of normal to normal (NN) intervals (ms) (VitaGuard® 3100 monitor, getemed, Germany).
-
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)
Root mean square of successive differences (ms) (VitaGuard® 3100 monitor, getemed, Germany).
-
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)
Percentage of successive NN intervals that differ from each other by more than 50 ms (%) (VitaGuard® 3100 monitor, getemed, Germany).
-
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).
-
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, %), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany).
-
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, %), obtained from pulse oximetry recordings throughout the intervention and the pre- and post-intervention rest periods (VitaGuard® 3100 monitor, getemed, Germany).
-
Evening morning protocol: perception of warmth and stimulus at the feet
Time frame: On the evening of the footbath, 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)
-
Evening morning protocol: skin condition
Time frame: On the evening of the footbath, 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)
-
Evening morning protocol: general well-being
Time frame: On the evening of the footbath, 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)
-
Morning protocol: sleep quality
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)
Sponsors and collaborators
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Other
Collaborators
- University Hospital Tuebingen
Registry information
Official study title
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design
Important dates
- Study start
- 2019
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Aug 9, 2019
- Registry last updated
- Apr 28, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.