A human study to evaluate toxic trace element detoxification, body fat reduction following four-week intake of the Wellnessup diet: a three-arm, randomized clinical trial
Abstract Background: Detox diet are known as a popular dieting strategies that helps toxins elimination and weight manage but there is very little clinical evidence. Methods: To evaluate the effects of 4 week intake of the Wellnessup diet (WD) on toxic trace element detoxification, body fat reduction, and safety parameters. Forty-five women with body mass index (BMI) of 23.5-30 kg/m 2 were recruited. Thirty of them were assigned 1:1 to the test group (WD, 15 subjects) and control group 1 (calorie-restricted diet, CRD, 15 subjects) in a single blind and randomized, and the remaining 15 subjects were assigned to control group 2 (maintaining regular diet, MRD). The primary outcome were toxic trace element levels in hair (29 types of heavy metals), and the secondary outcomes were changes in anthropometric and urinary organic acids. Results: The levels of four toxic trace elements in hair decreased in the WD group after the diet compared to before the diet. Ni, Rh, Sn, and Ga were significantly lower in the WD group than in the CRD or MRD group (p<0.05). A significant weight loss in both groups (WRD:-1.88±0.95kg; p<0.013, CRD:-3.22±0.48kg; p<0.01). The BMI, fat free mass and hip circumference (HC) of the CRD group were not only significantly decreased compared to the WD group but also Weight, BMI. Body fat mass, fat free mass, waist circumference, and HC were significantly decreased (p<0.05) compared to the MRD group, and the weight loss was a greater decrease was observed in the CRD group. No significant changes in any safety parameter were observed. Conclusions: Use of WD might have several beneficial effects and safety such as body fat reduction and improving some the element detoxification through caloric restriction but did not reducing body fat mass more than calorie-restricted diet.