Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design

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.

Study Overview

• Status: Completed
• Conditions: Thermogenesis by Different-dosage Ginger Flour Footbaths
• Intervention / Treatment: Other: 3-g footbath; Other: 6-g footbath; Other: 12-g footbath; Other: Warm water footbath

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3-g footbath; Footbath with 3g ginger flour per liter of water	Other: 3-g 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.
EXPERIMENTAL: 6-g footbath; Footbath with 6g ginger flour per liter of water	Other: 6-g footbath; 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.
EXPERIMENTAL: 12-g footbath; Footbath with 12g ginger flour per liter of water	Other: 12-g footbath; 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.
PLACEBO_COMPARATOR: Warm water 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), 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	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
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
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.	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.	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.	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).	Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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 (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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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)	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)	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)	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)	In the morning after the footbath, within 15 minutes after waking up

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2019
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (ACTUAL): August 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Healthy volunteers; Heart rate variability; Infrared thermography; Thermogenesis; Dose-response relationship; Ginger flour footbaths
• Other Study ID Numbers: SWI_08

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; 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