Studies

Health Optimizing ThyreoGym is manufactured and marketed as a wellness device for the stimulation of the thyroid gland. In a post-market, clinical follow-up study, performed in accordance with MEDDEV 2.12/2 re2, further clinical data was to be obtained to demonstrate the effectiveness and safety of the device. The primary effectiveness variable was the difference in body fat, skeletal muscle mass, BMI, and visceral fat region were also used as secondary variables. For data collection, a bioelectrical impedance analysis was performed with the InBody 720 using the Lookin’ Body Basic software to determine body composition before the study began then again after four and after eight weeks.

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From October 2012 to January 2013, a prospective, placebo-controlled, randomised, double-blind comparison was performed on 33 overweight patients with normal thyroid function. The eight-week applicable of Health Optimizing ThyreoGym without any change in lifestyle or eating habits during this period led to an average weight reduction of 2.0kg in overweight patients, while the average weight of the control group increased by 0.9kg over the same period. The group difference of 2.9kg is significant (p<0.01). In line with the weight loss observed in the intervention group that receive treatment and the increases in the placebo group, significant differences within the groups in terms of reductions or increases in the placebo group, significant differences within the groups in terms of reductions or increases could also be observed with the secondary effectiveness variables.

 

The differences in body fat mass was 1.5kg (p=0.03), 0.9kg (p=0.011) for skeletal muscle mass, 1.0kg/m2 (p<0.001) for BMI, and 6.1cm2 (p=0.012) for visceral fat levels. No unexpected events or side effects occurred as a result of using the device. The effectiveness and safety of Health Optimizing ThyreoGym was thereby confirmed.