Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers

NCT04321720 | Completed

• 1 other identifier: SWI_12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A study to explore whether different dosages of mustard flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

Conditions

Thermogenesis by Different-dosage Mustard Flour Footbaths

Keywords

Mustard flour footbaths; Dose-response relationship; Thermogenesis; Infrared thermography; Heart rate variability; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• 2-item warmth perception measure at the feet at time point 1 (t1) and time point 3 (t3)

  Immediately before (time point 1, t1) and 10 minutes following the footbath (time point 3, t3).

• 2-item warmth perception measure at the hands at t1, t2 and t3

  Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3).

• 2-item warmth perception measure at the head at t1, t2 and t3

  Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)

• 1-item overall warmth perception measure at t1, t2 and t3

  Immediately before (time point 1, t1), immediately after (time point 2, t2) and 10 minutes following the footbath (time point 3, t3)

• Warmth perception and skin stimulus at the feet during the footbath

  Up to 20 minutes

Study Arms (4)

3-g footbath

EXPERIMENTAL

Footbath with 3g mustard flour per liter of water

Other: 3-g mustard footbath

6-g footbath

EXPERIMENTAL

Footbath with 6g mustard flour per liter of water

Other: 6-g mustard footbath

12-g footbath

EXPERIMENTAL

Footbath with 12g mustard flour per liter of water

Other: 12-g mustard footbath

Warm water footbath

PLACEBO COMPARATOR

Footbath with warm water only

Other: Warm water only

Interventions

3-g mustard footbath OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.

3-g footbath

6-g mustard footbath OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.

6-g footbath

12-g mustard footbath OTHER

A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.

12-g footbath

Warm water only OTHER

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.

Warm water footbath

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent;
• Age between 18 and 55 years

You may not qualify if:

• Chronic skin lesions at the lower legs or feet
• Varicose veins grade 3 and grade 4 (Marshall stage classification)
• Chronic venous insufficiency
• Known intolerance or hypersensitivity to mustard preparations
• Cardiac arrhythmia
• Cardiac pacemaker
• Asthma bronchiale
• Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
• Pregnancy
• Insufficient knowledge of the german language

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead
• University Hospital Tuebingen: collaborator

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Study Officials

• Jan Vagedes, MD

  ARCIM Institute Academic Research in Complementary and Integrative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 25, 2020
• Study Start: April 20, 2020
• Primary Completion: August 25, 2020
• Study Completion: August 26, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

DE (1)