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）

• 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
• 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

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，因为骨骼在这几年中会迅速积累，并占成人峰值骨量 (PBM) 的一半，而成人峰值骨量 (PBM) 是晚年骨骼脆弱性的有力预测因素。这一时期的钙摄入量对于骨的充分矿化至关重要；如果低，可能会导致骨量低并增加骨折风险。钙是美国青少年饮食中最缺乏的营养素，只有 30% 的青少年符合建议。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，可改善矿物质的吸收并减少骨吸收。对大鼠的研究表明，与其他纤维相比，SCF 是能产生最大骨量和抗骨折能力的纤维。少数针对人类的研究表明，为青少年补充 SCF 可以最大程度地增加钙吸收，但尚不清楚这是否会转化为骨量的增加，特别是在青春期生长突增期间。因此，该提案的主要目的是确定与安慰剂相比，补充 SCF 1 年对成长中青少年骨代谢的影响。对于拟议的研究，将在 236 名 11-14 岁健康青少年中进行一项随机双盲安慰剂对照临床试验，同样随机分配到四个干预组之一：SCF（12 g/d）、SCF + 钙（12 g/d SCF + 600 mg/d 元素钙）、安慰剂（0 g/d SCF 或钙）和安慰剂 + 钙（0 g/d SCF + 600 mg/d）元素钙毫克/天）；全部每天给药两次。将在 6 个月和 12 个月时评估基线骨量，并在基线和 12 个月时评估骨相关生物标志物和粪便微生物组。评估访问将在佛罗里达国际大学斯坦普尔公共卫生学院临床研究中心进行。我们还将在 3 个月和 9 个月时进行短期家访，收集未使用的补充剂并提供更多补充剂。将在每次就诊时以及使用研究移动应用程序实时评估依从性。如果在饮食中补充 SCF 可以显着提高青春期的骨量，这可能有助于实现 PBM 的遗传潜力，并以更强壮的骨骼开始成年生活。与增加乳制品消费相比，在人群水平上用 SCF 强化不同的食物基质或补充剂可能是一种具有成本效益的骨骼健康干预措施，尤其是在青少年中。鉴于骨质疏松症危险因素的前身始于儿童/青少年期并一直延续到成年期，因此在这些阶段进行干预具有巨大的潜力，可以作为预防晚年骨质疏松性骨折并最大程度地减少其经济影响的手段。