Zalewski Bartłomiej Mateusz, Szajewska Hania
Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
BMJ Open. 2015 Apr 13;5(4):e007244. doi: 10.1136/bmjopen-2014-007244.
Glucomannan (GNN), a water-soluble dietary fibre derived from the plant Amorphophallus konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its actions are unclear. However, it has been shown that GNN slows gastric emptying by forming a viscous gel of large volume, which increases the feeling of satiety. Current evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials performed in children are needed to assess the efficacy of this modality. We aim to systematically evaluate the efficacy of GNN consumption for the management of children who are overweight or obese.
Children aged 6-17 years who are overweight or obese (based on the WHO growth criteria) will be randomly assigned to receive GNN or placebo (maltodextrin) (both at a dose of 3 g/day) for 3 months and will be followed-up for 3 months. Before the intervention, all children will receive dietetic advice, and they will be encouraged to engage in physical activity. The primary outcome measure will be the body mass index-for-age z-score difference between the groups at the end of the intervention.
The study was approved by the Bioethics Committee of the Medical University of Warsaw. The findings of this trial will be submitted to a peer-reviewed journal (paediatric, nutrition or gastroenterology). Abstracts will be submitted to relevant national and international conferences.
NCT02280772.
葡甘露聚糖（GNN）是一种从魔芋植物中提取的水溶性膳食纤维，市面上用于减肥。GNN发挥作用的确切机制尚不清楚。然而，已有研究表明，GNN通过形成大量粘性凝胶来减缓胃排空，从而增加饱腹感。目前关于GNN减肥效果的证据稀少，需要在儿童中进行精心设计的试验来评估这种方法的疗效。我们旨在系统评估食用GNN对超重或肥胖儿童的管理效果。
年龄在6至17岁的超重或肥胖儿童（根据世界卫生组织生长标准）将被随机分配接受GNN或安慰剂（麦芽糊精）（剂量均为3克/天），为期3个月，并进行3个月的随访。干预前，所有儿童将接受饮食建议，并鼓励他们进行体育活动。主要结局指标将是干预结束时两组之间年龄别体重指数z评分的差异。
该研究已获得华沙医科大学生物伦理委员会的批准。本试验的结果将提交给同行评审期刊（儿科、营养或胃肠病学领域）。摘要将提交给相关的国家和国际会议。
NCT02280772。
