Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Children: MetA-Bone Trial Study Protocol-Rationale and Design

OBJECTIVES: The adolescent period is crucial for optimizing future bone health because during these years bone accumulates rapidly accounting for up to half of adult peak bone mass (PBM). Calcium intake during this stage is critical for adequate bone mineralization but this essential nutrient, the major constituent of hydroxyapatite, is usually inadequate in the diets of US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption. This could be achieved by soluble corn fiber (SCF) supplementation, which fermentation through bacteria in the lower intestine produces short-chain fatty acids and increase calcium absorption. However, there are no studies determining the long-term effects of SCF on bone mass in children. The main aim of the MetA-Bone Trial is to determine the effect of one-year SCF supplementation compared to placebo on bone mass in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher Bone Mineral Content. We will also determine the effects of SCF supplementation on bone biomarkers; we hypothesize that supplementation with SCF will result in higher levels of bone formation and lower bone resorption biomarkers. METHODS: A total of 240 healthy children (10–13 years), with usual low dietary calcium, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo + 600 mg/d of calcium. The supplements will be mixed with a flavored powder beverage to dilute in water and participants will be instructed to drink this twice per day. Bone mass will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months. RESULTS: NA CONCLUSIONS: If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. Incorporating SCF into diets may be a cost-effective intervention for bone health than increasing dairy products consumption, particularly in adolescents. FUNDING SOURCES: Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health.