摘要：Background: Osteoporosis is characterized by reduced bone mineral density (BMD) and increased fracture risk, with a higher incidence in post-menopausal women. This study aimed to evaluate the safety and efficacy of long-term ingestion of maltobionic acid on BMD in healthy Japanese women. Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted from February to December 2018. Thirty-eight healthy Japanese women aged 50–69 years who were at least 1 year past the onset of natural menopause were allocated to two groups (19 in each group) using a computerized random-number generator: one in which participants ingested 7 g of corn syrup containing maltobionic acid and another in which participants ingested 7 g of placebo (maltose syrup) per day for 24 weeks. BMD and bone metabolism parameters were measured dualenergy X-ray absorptiometry (DEXA) method and a peripheral blood test, respectively, whereas safety was evaluated via a physical examination, peripheral blood test, urinalysis, assessment of subjective symptoms, and a medical questionnaire. Results: Of the 38 subjects, one subject discontinued the study halfway and 14 were excluded before the efficacy analysis because of conflicts with control criteria. Thus, the final study population was 23 subjects (10 in the Test food group and 13 in the Placebo group). There were no adverse events related to consumption of the test food. Consumption of corn syrup solids containing maltobionic acid was maintained during the intervention period, and BMD, bone mineral content, and young adult mean values were found to be improved (P < 0.05). No safety concerns were observed during the intervention period. Conclusion: These results indicate that the consumption of maltobionic acid may contribute to the prevention of osteoporosis.
关键词：Maltobionic acid; bone mineral density; safety; long-term intake; osteoporosis; menopause
