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Abstract:Background: olestra is a new type of fat substitutes. Because it is not absorbed, it may cause gastrointestinal Symptoms when consumed in large amounts. Objective: The aim was using cake as the carrier of olestra to compare the effect of gastrointestinal symptoms in people when consumed in different amounts. Methods: A randomized, double-blind, placebo-controlled trial compared the effects of olestra cake (11g/day or 22g/day in cake) with those of regular butter cake on gastrointestinal symptoms. The study lasted 9 days: 3days baseline and 6 days treatment. The gastrointestinal symptoms and their impact on daily activities were collected by telephone interviewers and recorded in a daily record. Results: Gastrointestinal symptoms, such as diarrhea, abdominal pain, flatulence, nausea, loose stools, more frequent bowel movement and so on, were observed in our study. The incidence of diarrhea (liquid/watery stools, bowel movement frequency > 3/day) which people and researchers paid more attention to was only 0.79% when one participant consumed 11g olestra. Of 63 evaluable subjects in the olestra cake group (22g/day) or in the butter cake group, incidence of GI adverse events was 1.6% lower than the incidence consumed 11g/day (6.4%). There was not significant difference between different intake doses in the incidence of gastrointestinal adverse events by chi-square (p=0.371>0.05). The incidence of gastrointestinal function change had a growing trend with the increase of olestra intake. But it is not significant by chi-square (p=0.541>0.05). Gastrointestinal symptoms, such as diarrhea, abdominal pain, flatulence, nausea, loose stools, mainly occurred in the first day after eating up cake, while more frequent bowel movement mainly occurred in the first and second day. The effect of sex and age on the incidence of gastrointestinal symptoms was not significant. Conclusions: This study demonstrates that consumption of olestra is not associated with increased incidence or severity of gastrointestinal symptoms. So it is safe and acceptable that olestra, as fat replacer, is applied in food. |