Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study).

Unlabelled: Soluble corn fibre (SCF) with calcium did not improve bone indices after 1 year in preadolescent children.

Introduction: SCF has been reported to improve calcium absorption. We investigated the long-term effect of SCF and calcium on bone indices of healthy preadolescent children aged 9-11 years old.

Methods: In a double-blind, randomised, parallel arm study, 243 participants were randomised into four groups: placebo, 12-g SCF, 600-mg calcium lactate gluconate (Ca) and 12-g SCF + 600-mg calcium lactate gluconate (SCF + Ca). Total body bone mineral content (TBBMC) and total body bone mineral density (TBBMD) were measured using dual-energy X-ray absorptiometry at baseline, 6 and 12 months.

Results: At 6 months, SCF + Ca had a significant increase in TBBMC from baseline (27.14 ± 6.10 g, p = 0.001). At 12 months, there was a significant increase in TBBMC from baseline in the SCF + Ca (40.28 ± 9.03 g, p = 0.001) and SCF groups (27.34 ± 7.93 g, p = 0.037). At 6 months, the change in TBBMD in the SCF + Ca (0.019 ± 0.003 g/cm) and Ca (0.014 ± 0.003 g/cm) groups was significantly different (p < 0.05) from SCF (0.004 ± 0.002 g/cm) and placebo (0.002 ± 0.003 g/cm). However, the changes in TBBMD and TBBMC were not significantly different among groups at 12 months.

Conclusion: SCF did not increase TBBMC and TBBMD in Malaysian children after 1 year although calcium supplementation increased TBBMD at 6 months. Further work is needed to fully understand the mechanism and health benefits of prebiotics in this study population.

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03864172.