Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals

Makers of ionic foot baths claim that their machines can eliminate heavy metals from the body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the machine under controlled conditions. The machine will first be tested without feet under normal operating conditions and again after operation under normal conditions with foot immersion.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: IonCLeanse Footbath

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E2
      • Canadian College of Naturopathic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Adults

Exclusion Criteria:

• A wearer of a pacemaker or any other battery operated or electrical implant
• Pregnant or nursing women
• On heartbeat regulating medication
• On blood thinners (anticoagulants)
• On any drug known to have chelating properties
• Have had an organ transplant or a metal joint implant
• On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Footbath; Participants in this arm of the study will receive 4 30 minutes ionic footbath sessions, one each week for 4 weeks.	Device: IonCLeanse Footbath; Application of an ionic footbath for 30 minutes per week for 4 weeks; Other Names: IonCleanse SOLO machine manufactured by A Major Difference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heavy metal content in the water after a 30 minute IonCleanse footbath	The footbath water will be assessed after each footbath session for each participant via a drinking water assessment performed by an accredited lab. Screening for heavy metals will be done via a 24 urine collection and Urine Toxic Metals assessment four times during the study - baseline, during 2nd and 4th footbath sessions and then at the 3 month mark post baseline.	4 sessions, May 26 to June 17 2010

Collaborators and Investigators

• Sponsor: The Canadian College of Naturopathic Medicine

Publications and helpful links

General Publications

• Kennedy DA, Cooley K, Einarson TR, Seely D. Objective assessment of an ionic footbath (IonCleanse): testing its ability to remove potentially toxic elements from the body. J Environ Public Health. 2012;2012:258968. doi: 10.1155/2012/258968. Epub 2011 Nov 29.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): November 15, 2011
• Last Update Submitted That Met QC Criteria: November 14, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: assess the ability of the IonCleanse machine to remove heavy metals through the feet
• Other Study ID Numbers: IonFootbath