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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

Tracking Information
First Submitted Date  ICMJE August 7, 2019
First Posted Date  ICMJE August 9, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04051476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers
Official Title  ICMJE Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Thermogenesis by Different-dosage Ginger Flour Footbaths
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 3-g footbath
    Footbath with 3g ginger flour per liter of water
    Intervention: Other: 3-g footbath
  • Experimental: 6-g footbath
    Footbath with 6g ginger flour per liter of water
    Intervention: Other: 6-g footbath
  • Experimental: 12-g footbath
    Footbath with 12g ginger flour per liter of water
    Intervention: Other: 12-g footbath
  • Placebo Comparator: Warm water footbath
    Footbath with warm water only
    Intervention: Other: Warm water footbath
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jan Vagedes, Dr. 49 711 7703 ext 1688 j.vagedes@arcim-institute.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04051476
Other Study ID Numbers  ICMJE SWI_08
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study Sponsor  ICMJE ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators  ICMJE University Hospital Tuebingen
Investigators  ICMJE
Principal Investigator: Jan Vagedes, Dr. Arcim Institute
PRS Account ARCIM Institute Academic Research in Complementary and Integrative Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP