The uric acid-lowering effect and safety of a fermented barley extract P (FBEP) prepared from barleyshochu distillery by-products were investigated in a randomized, placebo-controlled, parallel-group, doubleblinded study. A total of 111 subjects with serum uric acid levels of 6.0-7.9 mg/dl were provided with either a drink containing 2 g/d of FBEP (test group) or a placebo drink. After 12 weeks, the serum uric acid levels changed by À0:21 AE 0:56 mg/dl in the test group, showing a significant decrease in comparison to those of the placebo group (þ0:02 AE 0:54 mg/dl). Additionally, the uric acid clearance in the test group showed a tendency to increase after 12 weeks more than in the placebo group (p ¼ 0:054). No abnormalities in the physical and clinical tests were observed, and no adverse diagnostic findings were attributed to the intake of the test meal. These results demonstrated the benefits and safety of the FBEP treatment to subjects with slightly high serum uric acid or mild hyperuricemia.Key words: barley; shochu distillery by-product; uric acid; hyperuricemiaThe number of cases in Japan of gout and its cause, hyperuricemia, have been increasing yearly as a result of the adoption of westernized and Americanized diets. Even though there have been few epidemiological studies, the incidences of gout and hyperuricemia have also been increasing worldwide with changes in environmental factors.1,2) The Japanese Society of Gout and Nucleic Acid Metabolism defines hyperuricemia as a condition with over 7.0 mg/dl of serum uric acid, irrespective of the gender and age. Hyperuricemia has been attracting attention not only as the underlying cause of gout, but also as an independent predictive factor in cardiac and cerebrovascular disorders. 3,4) Hyperuricemia is classified into 3 types: the increased production type, in which uric acid is excessively produced; the decreased excretion type, in which the capability for uric acid excretion is reduced due to decreased renal function; and the mixed type, which is a combination of both the above types. Eighty-five percent of all the cases of gout and hyperuricemia in Japan involve decreased excretion of uric acid from the kidney.5,6) It has been reported that chitosan, as a foodstuff, decreases serum uric acid by inhibiting the absorption of purine.7) However, it has not been reported that a foodstuff can effectively decrease serum uric acid in humans by accelerating the uric acid excretion.We have studied the effective application of shochu distillery by-products (SDB) and have reported the effects of a fermented barley extract (FBE) obtained from barley-SDB. The effects of FBE on preventing fatty liver induction by orotic acid, 8) preventing liver injury caused by D-galactosamine 9) and preventing alcohol-induced liver injury have been reported.
10)Additionally, in an exploratory open study, we have reported that supplementation with FBEP at a dose of 2 g/d reduced serum uric acid in subjects with slightly high serum uric acid or mild hyperuricemia.11) The present stud...