Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

Not Applicable

Completed

Conditions: Thermogenesis by Different-dosage Ginger Flour Footbaths

Interventions: Other: 6-g footbath
Other: 3-g footbath
Other: Warm water footbath
Other: 12-g footbath

Registration Number: NCT04051476

Lead Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
6-g footbath	6-g footbath	Footbath with 6g ginger flour per liter of water
3-g footbath	3-g footbath	Footbath with 3g ginger flour per liter of water
Warm water footbath	Warm water footbath	Footbath with warm water only
12-g footbath	12-g footbath	Footbath with 12g ginger flour per liter of water

Primary Outcome Measures

Name	Time	Method
2-item warmth perception measure at the feet after the footbath	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 Outcome Measures

Name	Time	Method
Well-being at t1, t2 and t3	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.)
2-item warmth perception measure at the feet at t1 and t3	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	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.
Skin surface temperature at the lower legs at t1, t2 and t3	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).
1-item overall warmth perception measure at t1, t2 and t3	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).
2-item warmth perception measure at the head at t1, t2 and t3	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.
HRV analysis: SDNN	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).
Warmth perception and skin stimulus at the feet during the footbath	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).
Skin surface temperature at the feet at t1, t2 and t3	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 hands at t1, t2 and t3	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).
Evening morning protocol: skin condition	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	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	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)
Skin surface temperature in the face at t1, t2 and t3	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	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	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	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: RMSSD	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	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	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	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	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	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)

Trial Locations

Locations (1): Arcim Institute
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Filderstadt, Baden-Württemberg, Germany