Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

April 27, 2020 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the footbath, timepoint 2 (t2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Up to 20 minutes
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.
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).
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
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.
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)
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
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.)
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 (°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
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).
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).
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).
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).
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)
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
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).
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)
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
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).
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)
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
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).
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)
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
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).
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
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
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)
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
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
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)
In the morning after the footbath, within 15 minutes after waking up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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