A randomized, double-blind placebo controlled cross-over study to investigate the effects of RW94 on the absorption of dietary fat in healthy volunteers.
RW94 is a permitted additive in the food industry, which precipitates fatty acids in vitro. In vivo, this could result in reduced fatty acid absorption by the body, and may, therefore, influence the amount of fat excreted in the faeces. An investigation into the effects of RW94 on bodily fat absorption and excretion was undertaken. The safety, tolerability and efficacy of the product was compared with placebo in a group of 12 healthy volunteers, randomly assigned to receive either RW94 or placebo for a period of four days when dietary fat intake was controlled. After a 10-day washout period, the randomly assigned groups were crossed over to receive placebo and RW94, respectively, for a second 4-day period, when fat intake was similarly controlled. Five grams of RW94 administered orally 30 min after each meal resulted in a statistically significant increase in the amount of excreted faecal lipids compared with placebo (p < 0.05). Following high fat intake, total blood cholesterol was predictably raised in both placebo and RW94 groups, but was less markedly raised with RW94 than placebo. All subjects lost body weight during the study, but the loss while consuming RW94 was significantly greater (p < 0.05) than while consuming placebo. All subjects found the treatments acceptable, though an increased incidence of flatulence, rumbling stomach and abdominal discomfort was noted with RW94 compared with placebo. RW94 was comparable with placebo in respect of safety.
Williams
A R
AR
Department of Medical Biophysics, University of Manchester Medical School, England.
Turkie
W H
WH
D000328:Adult; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D005223:Fats / Q000032:analysis; D005227:Fatty Acids / Q000493:pharmacokinetics*; D005243:Feces / Q000737:chemistry; D005414:Flatulence / Q000139:chemically induced; D005503:Food Additives / Q000494:pharmacology*; D006801:Humans; D006937:Hypercholesterolemia / Q000517:prevention & control; D007408:Intestinal Absorption / Q000187:drug effects*; D008055:Lipids / Q000097:blood; D009765:Obesity / Q000517:prevention & control
D004041:Dietary Fats; D005223:Fats; D005227:Fatty Acids; D005503:Food Additives; D008055:Lipids