Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Summary
The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF) supplementation for 1 year on bone metabolism in growing adolescents compared to controls. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 10-13 years, equally randomly assigned to one of four intervention groups: SCF (12 g/d), SCF + calcium (12 g/d of SCF + 600 mg/d of elemental calcium), placebo (0 g/d of SCF or of calcium), and placebo + calcium (0 g/d of SCF + 600 mg/d of elemental calcium); all administered twice a day. Bone mass will be assessed at baseline at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months.
Timeline
- Start
- 2020-02-10
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Soluble Corn Fiber (SCF) Without Calcium vs Placebo; p = 0.377; Mean Difference (Net) 1.7 (95% CI -2.12 to 5.53) NCT02916862 ↗
registry analysis (superiority test); Soluble Corn Fiber (SCF) + Calcium vs Placebo + Calcium; p = 0.245; Mean Difference (Net) 1.950 (95% CI -1.366 to 5.266) NCT02916862 ↗
Publications
- Palacios C, Trak-Fellermeier MA, Hernandez J, Galvan R, Martinez-Motta P, Machi A, Sifre-Acosta N, Clayton PK, Hernandez Y, Martinez R, Gambon T, Bursac Z, Weaver CM. Effect of soluble corn fiber supplementation for 1 year on bone mass in children and adolescents: results from the MetA-Bone randomized clinical trial. Am J Clin Nutr. 2026 Jun;123(6):101305. doi: 10.1016/j.ajcnut.2026.101305. Epub 2026 Apr 3.
- Palacios C, Leone J, Clayton P, Hernandez J, Trak-Fellermeier MA, Macchi A, Ramirez-Roggio D, Cobo Y, Bautista S, Connelly J, Elington M, Romero J, Galvan R. Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children. Contemp Clin Trials. 2024 Dec;147:107715. doi: 10.1016/j.cct.2024.107715. Epub 2024 Oct 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium carbonate | Other / unclassified | 600 mg | — |
| Subject | Soluble Corn Fiber | Unknown | 12 g | — |