This was a proof-of-principle, nonrandomized, nonblinded comparative, no feet versus feet, trial conducted from the week of May 17, 2010 (Week 0) through to August 9, 2010 (Week 12). Ethics approval was given by Research Ethics Board of the Canadian College of Naturopathic Medicine (CCNM) according to the ethical standards set forth in the 1975 Helsinki Declaration. All participants enrolled gave written informed consent to participate in the study. This study was funded through a grant from the Holistic Health Research Foundation. The trial registry number is > NCT01125592.
2.1.3. Setup and Running of the Footbath Device.
Following an empty search of Medline, EMBASE, AMED, Alt Health Watch, and CINAHL using the search terms “ionic,” “footbath,” and “detoxification,” a search on Google found one study conducted by the Centre for Research Strategies . That study found a statistically significant reduction in aluminum and arsenic, but no changes in lead, mercury, or cadmium in whole blood of the participants after 12 weekly sessions . Concomitant nutrition and meditation techniques were used, making the contribution from footbaths impossible to isolate. In addition there was a risk of bias for this study demonstrated by poor quality reporting (12-week results reported only yet the protocol described a 6-month study), a lack of scientific rigor in the methods, and potential for conflict of interest, the research was conducted by “The Centre for Research Strategies,” an arm of the IonCleanse manufacturer. Unbiased, reliable information on prevalence of consumer use, as well as scientific investigation of the methods and purported effects of these devices, remains scarce.
2.1. Study Design.
2.1.2. Ionic Footbath Device.
Between April and May 2010, healthy participants were recruited through e-mail to CCNM staff and students, website-based advertisements, and posters. The e-mail summarized the requirements for the study and asked interested individuals to respond to the study coordinator. The study was also open to the general public.
IonCleanse SOLO (A Major Difference Inc., Aurora, Colo) ionic footbath was used for all sessions in the study. With knowledge of the trial to be conducted, A Major Difference Inc. donated an IonCleanse SOLO machine for the duration of this study. The components of the ionic footbath include the SOLO device, an array, a power cord, plastic foot tub liners, and a plastic foot tub container ( Figure 1 ). The SOLO device has a single preset program to generate a 70/30 mix of positive/negative polarity in a standard 30-minute session.