Effect of Soluble Corn Fiber supplementation for 1 year on bone metabolism in adolescents (MetA-Bone Trial)

补充可溶性玉米纤维一年对青少年骨代谢的影响（MetA-Bone 试验）

基本信息

批准号：
10728401
负责人：
CRISTINA PALACIOS
金额：
$ 7.26万
依托单位：
FLORIDA INTERNATIONAL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-11 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10728401
关键词：
15 year old Adolescence Adolescent Adult Award Bacteria Beverages Biological Markers Bone Mineral Contents Bone Resorption Calcium Carbohydrates Childhood Clinical Research Clinical Trials Data Monitoring Committees Consent Forms Consumption Controlled Clinical Trials Cross-Over Studies Dairy Products Diet Double-Blind Method Elements Fermentation Fiber Florida Food Fracture Future Genetic Grant Growth Home visitation Human Individual Institution International Intestines Lead Life Long-Term Effects Manuals Methods Minerals National Institute of Child Health and Human Development Nutrient Oligosaccharides Osteogenesis Osteoporosis Osteoporosis prevention Physiologic calcification Placebo Control Placebos Population Powder dose form Protocols documentation Public Health Schools Puerto Rico Questionnaires Randomized Rattus Recommendation Reporting Research Personnel Resistance Risk Risk Factors Safety Skeleton Supplementation Testing Time Translating Universities Visit Vitamin D Volatile Fatty Acids Weight absorption aged bone bone fragility bone health bone loss bone mass bone metabolism calcium absorption calcium intake calcium supplementation comparison control cost effective intervention cost estimate critical period density design dietary supplements economic impact fecal microbiome fortification fracture risk girls group intervention gut bacteria gut microbiome improved meetings microbiome analysis mobile application operation osteoporosis with pathological fracture osteoporotic bone prevent randomized, clinical trials recruit screening time use

项目摘要

Adolescence is crucial for optimizing future bone health because bone accumulates rapidly during these years and accounts for up to half of adult peak bone mass (PBM), which is a strong predictor of bone fragility later in life. Calcium intake during this period is critical for adequate bone mineralization; if low, it could lead to low bone mass and increased risk of fractures. Calcium is the nutrient most deficient in the diets of US adolescents, with only 30% meeting the recommendation. A strategy to maximize bone mineralization in adolescence is to increase calcium absorption, which could be achieved by supplementation with non-digestible carbohydrates, such as soluble corn fiber (SCF). SCF is fermented by gut bacteria producing short-chain fatty acids, which improves absorption of minerals and could decrease bone resorption. Studies in rats show that SCF is the fiber that results in the greatest bone mass and resistance to fractures compared to other fibers. The few studies in humans show that supplementing adolescents with SCF results in the greatest increase in calcium absorption but it is not known if this translates into an increase in bone mass, particularly during the period of adolescence growth spurt. Therefore, the primary aim of this proposal is to determine the effects of SCF supplementation for 1 year on bone metabolism in growing adolescents compared to placebo. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 11-14 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. Assessment visits will be conducted in the Clinical Research Center of the Stempel School of Public Health at Florida International University. We will also have short home visits at 3 and 9 months to collect unused supplements and provide more supplements. Compliance will be evaluated at all visits and also in real time using a study mobile app. If supplementing diets with SCF lead to significantly higher bone mass in adolescence, this could help to achieve the genetic potential for PBM and to start adult life with stronger bones. Fortifying different food matrices or supplements with SCF may be a cost-effective intervention at the population level for bone health than increasing dairy products consumption, particularly in adolescents. Given that the antecedents to osteoporosis risk factors begin in childhood/adolescence and track into adulthood, intervening at these stages has tremendous potential as means for preventing osteoporotic fractures later in life and minimizing its economic impact.

青春期对于优化未来的骨骼健康至关重要，因为在这些年中骨骼会迅速积累，并且最多占成年峰骨量（PBM）的一半，这是较晚生活中骨骼脆弱性的有力预测指标。在此期间的钙摄入量对于足够的骨矿化至关重要。如果低，则可能导致骨骼质量低，骨折风险增加。钙是美国青少年饮食中最不足的营养素，只有30％符合建议。一种最大化青春期骨矿化的策略是增加钙吸收，这可以通过补充不可消化的碳水化合物（例如可溶性玉米纤维（SCF））来实现。 SCF由肠道细菌发酵，产生短链脂肪酸，从而改善矿物质的吸收，并可以减少骨吸收。在大鼠中的研究表明，与其他纤维相比，SCF是导致骨骼质量最大和骨折的耐药性的纤维。人类中的少数研究表明，补充SCF的青少年会导致钙吸收的最大增加，但尚不清楚这是否转化为骨骼质量的增加，尤其是在青春期生长时期。因此，与安慰剂相比，该提案的主要目的是确定1年补充SCF对骨代谢的影响。 For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 11-14 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的元素钙）;每天两次管理。将在6个月和12个月的基线评估骨骼质量，与骨相关的生物标志物和粪便微生物组将在基线和12个月时进行评估。评估访问将在佛罗里达国际大学的Stempel公共卫生学院的临床研究中心进行。我们还将在3个月和9个月的时间进行短暂的家庭访问，以收集未使用的补品并提供更多补品。合规性将在所有访问中进行评估，并使用研究移动应用程序实时评估。如果补充SCF的饮食会导致青春期明显更高的骨量，这可能有助于获得PBM的遗传潜力，并以更强的骨骼开始成人生活。与增加乳制品的消费量相比，使用SCF加固不同的食物矩阵或补充剂可能是骨骼健康的成本效益干预措施，尤其是在青少年中。鉴于骨质疏松症危险因素的先例始于儿童/青春期，并进入成年期，因此在这些阶段进行介入具有巨大的潜力，作为预防骨质疏松性骨折的手段，并最大程度地减少其经济影响。