Beneficial effects of maltobionic acid on bone density in healthy Japanese adult women: A randomized double-blind placebo-controlled study

Abstract

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 corn syrup solids containing 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) group per day for 24 weeks. BMD and bone metabolism parameters were measured by DEXA (dual-energy X-ray absorptiometry method) and a peripheral blood test, respectively, while safety was evaluated via a physical examination, peripheral blood test, urinalysis, assessment of subjective symptoms, and a medical questionnaire.

Results: Thirty-three subjects completed the study, except for one subject who discontinued the study halfway, and there were no adverse events related to consumption of the test food. Fourteen subjects were excluded before the efficacy analysis because of conflict with control criteria; the remaining 23 subjects were studied (10 in the Test food group and 13 in the Placebo group). Consumption of corn syrup solids containing maltobionic acid was maintained during the intervention period, and BMD, bone mineral content (BMC), and YAM (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 corn syrup solids containing maltobionic acid may contribute to the prevention of osteoporosis.