Thermogenesis by Different-dosage Ginger Flour FootbathsNCT04051476
Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers
A study testing 3-g footbath, 6-g footbath and 12-g footbath in people with Thermogenesis by Different-dosage Ginger Flour Footbaths, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermogenesis by Different-dosage Ginger Flour Footbaths
- What is being tested?
- 3-g footbath, 6-g footbath and 12-g footbath
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Age between 18 and 55 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- 3-g footbath, 6-g footbath, 12-g footbath, Warm water footbath
- Keywords
- Ginger flour footbaths, Dose-response relationship, Thermogenesis, Infrared thermography, Heart rate variability, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-g footbathOther
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.
6-g footbathOther
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.
12-g footbathOther
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.
Warm water footbathOther
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 group | Role | What they receive |
|---|---|---|
| 3-g footbath | Experimental | Footbath with 3g ginger flour per liter of water Receives: Other: 3-g footbath |
| 6-g footbath | Experimental | Footbath with 6g ginger flour per liter of water Receives: Other: 6-g footbath |
| 12-g footbath | Experimental | Footbath with 12g ginger flour per liter of water Receives: Other: 12-g footbath |
| Warm water footbath | Placebo comparator | Footbath with warm water only Receives: Other: Warm water footbath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the footbath, timepoint 2 (t2)
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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).
Measured: Up to 20 minutes
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.)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: In the morning after the footbath, within 15 minutes after waking up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start16 Sep 2019
- Primary completion30 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermogenesis by Different-dosage Ginger Flour FootbathsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Principal investigator, Arcim Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051476
- Sponsor's protocol ID
- SWI_08
- Status last verified
- Apr 2020
- First submitted
- 7 Aug 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers - a Randomized, Controlled, Four-Arm Study With Crossover Design
- ClinicalTrials.gov ID
- NCT04051476
- Acronym / sponsor ID
- SWI_08
- Keywords
- Ginger flour footbaths, Dose-response relationship, Thermogenesis, Infrared thermography, Heart rate variability, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3-g footbath | Experimental | Other: 3-g footbathFootbath with 3g ginger flour per liter of water |
| 6-g footbath | Experimental | Other: 6-g footbathFootbath with 6g ginger flour per liter of water |
| 12-g footbath | Experimental | Other: 12-g footbathFootbath with 12g ginger flour per liter of water |
| Warm water footbath | Placebo comparator | Other: Warm water footbathFootbath with warm water only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent
- Age between 18 and 55 years
Key exclusion criteria (8 listed)
- Chronic skin lesions at the lower legs or feet
- Known intolerance or hypersensitivity to ginger preparations
- Cardiac arrhythmia
- Cardiac pacemaker
- Asthma bronchiale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-g footbathA 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 | 3-g footbath |
| 6-g footbathA 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 | 6-g footbath |
| 12-g footbathA 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 | 12-g footbath |
| Warm water footbathA 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. | Other | Warm water footbath |
Primary outcome
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.
23 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)
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).
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)
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)
Warmth perception and skin stimulus at the feet during the footbath
Time frame: Up to 20 minutes
Well-being at t1, t2 and t3
Time frame: Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)
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 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 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 in the face at t1, t2 and t3
Time frame: 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)
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)
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)
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)
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)
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)
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 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)
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)
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
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
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
Morning protocol: sleep quality
Time frame: In the morning after the footbath, within 15 minutes after waking up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, Dr. principal investigator
Arcim Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-g footbath, 6-g footbath and 12-g footbath in people with Thermogenesis by Different-dosage Ginger Flour Footbaths, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-item warmth perception measure at the feet after the footbath (time frame: Immediately after the footbath, timepoint 2 (t2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.