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

NCT01125592 | Completed Early Phase 1

• 1 other identifier: IonFootbath
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

assess the ability of the IonCleanse machine to remove heavy metals through the feet

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Footbath

EXPERIMENTAL

Participants in this arm of the study will receive 4 30 minutes ionic footbath sessions, one each week for 4 weeks.

Device: IonCLeanse Footbath

Interventions

IonCLeanse Footbath DEVICE

Application of an ionic footbath for 30 minutes per week for 4 weeks

Also known as: IonCleanse SOLO machine manufactured by A Major Difference

Footbath

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Adults

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead

Study Sites (1)

Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 22174728 RESULT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research & Clinical epidemiology

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 15, 2011

Record last verified: 2011-11

Locations

CA (1)