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Nonalcoholic fatty liver disease (NAFLD) is the most prevalent form of chronic liver disease worldwide and is an increasing cause of liver-related morbidity and mortality. Nonalcoholic steatohepatitis (NASH), the progressive histological subtype of the disease, is a growing target for drug design and development. Currently, no effective drug therapies exist for the management of NASH and multiple challenges exist for NASH-related clinical trials, stressing the need for a focused deliberative approach to facilitate drug development. One such challenge includes the inconsistent measurement of baseline parameters across clinical trials, which makes interpretation and comparison of trial data difficult and impedes drug development effort.

Objectives We aimed to assess in healthy subjects 1) the effect of two doses of a new naturally inulin-rich soluble chicory extract (IRSCE) on overall gastrointestinal discomfort after short-term ingestion and 2) the effect on gastrointestinal symptoms of long-term consumption of IRSCE administered at a dose compatible with its future commercial use. Methods First, the effect of IRSCE was assessed on overall gastrointestinal discomfort in a double-blind, crossover study where 18 subjects received in a randomized order a morning coffee drink including 10 g of sucrose alone (control period) or with IRSCE at two doses (8.9 and 14.0 g containing 5.0 and 7.8 g of inulin, respectively) during three consecutive 6-d periods. Second, 35 subjects were followed during a randomized, double-blind protocol where they were asked to take twice a day an instant coffee drink containing IRSCE (8.1 g/d containing inulin 5.0 g/d) or sucrose 8.1 g/d during 4 wk. The effects of the treatment on flatulence, bloating, abdominal pain, stool consistency, and number were recorded. Results In the first study a significant slight increase (P = 0.05) in overall abdominal discomfort was observed with the morning coffee drink containing 7.8 g of inulin after 1 wk of consumption. In the second study, no significant differences between the IRSCE and placebo groups were evidenced with respect to gastrointestinal symptoms during the consumption period. Conclusion Short- and long-term consumptions of IRSCE, given at a daily dose containing 5 g of inulin, are well tolerated by healthy subjects.