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Safety Evaluation of Long—term Intake and Effects on Bone Mineral Density of Corn Syrup Solids Containing Maltobionic Acid (Maltobionic Acid Calcium Salt) in Healthy Japanese Women ―A Randomized Double—blind Placebo—controlled Study―
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JPY
Abstract
Background/Objectives To evaluate the influence of the long-term ingestion of corn syrup solids containing maltobionic acid(maltobionic acid calcium salt)on the bone mineral density(BMD)and safety of healthy Japanese women. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study. Thirty-four healthy Japanese women aged 50-69 years who were at least 1 year past the onset of natural menopause were allocated into two groups: one in which participants ingested 8 g of corn syrup solids containing maltobionic acid calcium salt and another in which participants ingested 8 g of placebo(hydrous crystalline maltose and calcium carbonate) group per day for 24 weeks. BMD measurements(dual-energy X-ray absorptiometry method)and bone metabolism parameter measurements were evaluated by a peripheral blood test, while safety was evaluated by a physical examination, a peripheral blood test, a urinalysis, subjective symptoms, and a medical questionnaire. Results All 34 subjects completed the study with no adverse events related to the test food. Fifteen subjects were excluded before the efficacy analysis because of conflict with control criteria; the remaining 19 subjects were analyzed. Consumption of corn syrup solids containing maltobionic acid was maintained, and BMD, bone area, and bone mineral content (BMC)were improved. Conclusions These results indicate that corn syrup solids containing maltobionic acid might contribute to the prevention of osteoporosis(. UMIN︱CTR ID:UMIN 000025401)
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