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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)

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Abstract

Summary

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/cm2) and Ca (0.014 ± 0.003 g/cm2) groups was significantly different (p < 0.05) from SCF (0.004 ± 0.002 g/cm2) and placebo (0.002 ± 0.003 g/cm2). 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

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Data availability

The data described in the manuscript will be made available upon request pending approval.

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Acknowledgements

The authors thank all the participants, parents and teachers as well as research assistants/enumerators in this study.

Funding

This research was funded by Tate & Lyle PLC, UK.

Author information

Authors and Affiliations

  1. Division of Nutrition & Dietetics, School of Health Sciences, International Medical University, Kuala Lumpur, Malaysia

    Kanimolli Arasu, Chung Yuan Chang, Soon Yee Wong, Wai Yew Yang, Megan Hueh Zan Chong & Winnie Siew Swee Chee

  2. Institute of Research, Development and Innovation, International Medical University, Kuala Lumpur, Malaysia

    Shu Hwa Ong

  3. Department of Paediatrics, School of Medicine, International Medical University, Seremban, Malaysia

    Meenal Mavinkurve & Erwin Jiayuan Khoo

  4. Faculty of Business and Management, UCSI University, Kuala Lumpur, Malaysia

    Karuthan Chinna

  5. San Diego State University, San Diego, CA, USA

    Connie M. Weaver

Authors
  1. Kanimolli Arasu
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Corresponding author

Correspondence to Winnie Siew Swee Chee.

Ethics declarations

Statement of human and animal rights

The study has been approved by the Research and Ethics Committee of the International Medical University (IMU R/2016), and the trial was registered in clinicaltrials.gov (NCT03864172). The study was approved to be conducted in schools by the Ministry of Education, Malaysia (KPMSP.600–3/2/3). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Conflicts of interest

None.

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The sponsors of the study had no role in study design, data collection, data analysis and interpretation. All authors had full access to all the data and are collectively responsible for the decision to submit for publication.

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Arasu, K., Chang, C.Y., Wong, S.Y. et al. 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). Osteoporos Int 34, 783–792 (2023). https://doi.org/10.1007/s00198-023-06702-0

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