Gastrointestinal tolerance of gamma-cyclodextrin in humans

The gastrointestinal tolerance of gamma-cyclodextrin (gamma-CD) was examined in 24 healthy human volunteers. In a double-blind, placebo-controlled, randomized cross-over study, single acute doses of 8 g maltodextrin (placebo) or 8 g gamma-CD (test) were consumed as a mid-morning snack after addition to 100 g yogurt. Gastrointestinal symptoms as well as frequency and consistency of stools were recorded before and after lunch at between 3-4 and 7-8 h after intake respectively. The perception of the symptoms was rated on a subjective scale ranging from 1 ('more than normal') to 3 ('exceptionally more than normal'). Following consumption of maltodextrin, five subjects reported a total of 12 symptoms of which seven, two and three were rated as having grade 1, 2 and 3, respectively. Following consumption of gamma-CD, five subjects reported six symptoms all of which were graded as 1. Two subjects reported flatulence, which is a frequent consequence of the consumption of malabsorbed carbohydrates, after placebo and test treatment. The incidence of individual and combined side-effects as well as the number and consistency of faeces passed was not significantly different between placebo and test treatment. It is concluded that single doses of 8 g gamma-CD and maltodextrin are tolerated equally well. This is in keeping with a good digestibility of gamma-CD by salivary and pancreatic amylase.