Dose-Response Relationship of Ginger Flour Footbaths in Healthy Volunteers

NCT04051476 | Completed

• 1 other identifier: SWI_08
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Thermogenesis by Different-dosage Ginger Flour Footbaths

Keywords

Ginger 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 t1 and t3

  Immediately before (t1) and 10 minutes following the footbath (t3)

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

  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

  Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (t3)

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

  Immediately before (t1), immediately after (t2) and 10 minutes following the footbath (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 ginger flour per liter of water

Other: 3-g footbath

6-g footbath

EXPERIMENTAL

Footbath with 6g ginger flour per liter of water

Other: 6-g footbath

12-g footbath

EXPERIMENTAL

Footbath with 12g ginger flour per liter of water

Other: 12-g footbath

Warm water footbath

PLACEBO COMPARATOR

Footbath with warm water only

Other: Warm water footbath

Interventions

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

3-g footbath

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

6-g footbath

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

12-g footbath

Warm water footbath 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
• 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

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, Dr.

  Arcim Institute

  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: August 7, 2019
• First Posted: August 9, 2019
• Study Start: September 16, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 31, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

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)