Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers

NCT ID: NCT04321720

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2020-08-26

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.

Detailed Description

This is a blinded, four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of mustard 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.

Conditions

Thermogenesis by Different-dosage Mustard Flour Footbaths

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

3-g footbath

Footbath with 3g mustard flour per liter of water

Group Type: EXPERIMENTAL

3-g mustard footbath

Intervention Type: 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.

6-g footbath

Footbath with 6g mustard flour per liter of water

Group Type: EXPERIMENTAL

6-g mustard footbath

Intervention Type: 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.

12-g footbath

Footbath with 12g mustard flour per liter of water

Group Type: EXPERIMENTAL

12-g mustard footbath

Intervention Type: 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.

Warm water footbath

Footbath with warm water only

Group Type: PLACEBO_COMPARATOR

Warm water only

Intervention Type: 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.

Interventions

3-g mustard 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 mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type: OTHER

6-g mustard 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 mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type: OTHER

12-g mustard 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 mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.

Intervention Type: OTHER

Warm water only

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, MD

Role: PRINCIPAL_INVESTIGATOR

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Locations

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

SWI_12

Identifier Type: -

Identifier Source: org_study_id