A Double-blind, Placebo-controlled Evaluation of the Effects of RW94 on the Body Weight of Both Overweight and Obese Healthy Volunteers

RW94 is a naturally occurring common inorganic substance and a permitted additive in the food industry which binds to and precipitates free fatty acids in vitro. Our preliminary clinical trial showed a statistically significant increase in the quantity of faecal fat excreted by volunteers who had consumed RW94, showing that the fatty acids were also precipitated and not absorbed in vivo. It is therefore anticipated that RW94 will aid weight loss by preventing the absorption of some of the dietary fat. Five grams of RW94 were administered orally after each main meal to half of a group of 32 overweight or obese, but otherwise healthy, volunteers, the others receiving a placebo of maize starch. There was a statistically significant (p < 0.05) reduction in the mean weights of the RW94 group relative to their controls at three weeks, and this reduction was maintained throughout the remainder of the six-week trial period. In accordance with our previous findings, there was a higher incidence of abdominal discomfort, rumbling stomach and flatulence among the RW94 group, reflecting the possible transient changes in the bacterial ecosystem of the lower gut in response to the increased delivery of nutrients. These adverse events diminished as the bacteria apparently re-established equilibrium. It appears that the incidence of abdominal discomfort in its various forms following consumption of RW94 is lower than that initially indicated in the preliminary study. Thus, this second clinical trial performed under conditions approximating to the 'real life' situation confirmed that RW94 appears to help reduce the increase in weight following the consumption of excessive dietary fat without undue discomfort or inconvenience from adverse sequellae.