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Abstract
The gastrointenstinal tolerance of γ-cyclodextrin (γ-CD) was examined in 24 healthy human volunteers. In a double-blind, placebo-controlled, randomized crossover study, single acute doses of 8g maltodextrin (placebo) or 8g γ-CD (test) were consumed as a mid-morning snack after addition to 100g yogurt. Gastrointenstinal symptoms as well as frequency and consistency of stools were recorded before and after lunch at between 3–4 and 7–8h 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 γ-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 8g γ-CD and maltodextrin are tolerated equally well. This is in keeping with a good digestibility of γ-CD by salivary and pancreatic amylase.