In June 2012, Kemin submitted a dossier pursuant to the Article 13.5 of Regulation (EC) 1964/2006 based on proprietary data, which included four unpublished pertinent human studies on weight loss, one unpublished meta-analysis and 12 supportive published and unpublished human intervention trials offered on the effects of Slendesta and potato extract on gastric emptying, post-prandial blood glucose concentrations and increases in satiety measurements, and cholecystokinin (CCK) concentrations.
The core pertinent weight loss “RTL” study was a multi-center, randomized, controlled clinical trial with 240 overweight and obese subjects. The company stated that it was designed to show and did in fact show that Slendesta had a statistically significant placebo-adjusted reduction in weight loss over baseline after the end of the 12-week study intervention in the 30 mg treatment group (p = 0.0464). Moreover, when the RTL study results were analyzed according to weight changes in the proposed health claim target group of 135 overweight subjects only, the 30 mg dose of Slendesta resulted in a highly statistically significant placebo-subtracted reduction in body weight from baseline at eight weeks (p = 0.0146), at the end of the study (p = 0.0052), as well as a statistically significant effect over time (treatment x time interaction (p= 0.0457)) and a statistically significant treatment main effect (p = 0.0458).
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