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Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04051476
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thermogenesis by Different-dosage Ginger Flour Footbaths Other: 3-g footbath Other: 6-g footbath Other: 12-g footbath Other: Warm water footbath Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. 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.

  3. 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.

  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).

  5. 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).

  6. 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.)

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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)

  21. 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)

  22. 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)

  23. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051476


Contacts
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Contact: Jan Vagedes, Dr. 49 711 7703 ext 1688 j.vagedes@arcim-institute.de

Locations
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Germany
Arcim Institute Recruiting
Filderstadt, Baden-Württemberg, Germany, 70794
Contact: Jan Vagedes, Dr.    49 711 7703 ext 1688    j.vagedes@arcim-institute.de   
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
University Hospital Tuebingen
Investigators
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Principal Investigator: Jan Vagedes, Dr. Arcim Institute

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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT04051476     History of Changes
Other Study ID Numbers: SWI_08
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will be made available upon publication for a duration of three months.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Ginger flour footbaths
Dose-response relationship
Thermogenesis
Infrared thermography
Heart rate variability
Healthy volunteers