Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- diarrhea
研究概览
简要总结
This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.
详细描述
A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tube-feeding patients
排除标准
- •EN prohibited
- •renal dysfunction (i.e. serum creatinine > 1.5 mg/dl or blood urea nitrogen > 25 mg/ml)
- •liver dysfunction (i.e. serum aspartate aminotransferase > 40 U/L or alanine aminotransferase > 40 U/L)
- •uncontrollable diabetes mellitus
- •pregnancy, breast-feeding etc.
- •severe diarrhea
研究组 & 干预措施
low FODMAP group
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
干预措施: low FODMAP (Dietary Supplement)
moderate FODMAP group
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
干预措施: moderate FODMAP (Dietary Supplement)
high FODMAP group
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
干预措施: high FODMAP (Dietary Supplement)
结局指标
主要结局
diarrhea
时间窗: 14-day follow-up
次要结局
- prealbumin(14-day follow-up)
- body mass index(14-day follow-up)
研究者
Oh Yoen Kim
Assistant Professor
Dong-A University