Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Gastric emptying
研究概览
简要总结
Research has demonstrated that there is a relationship between malnourishment and insufficient production of pancreatic enzymes, such as α-amylase which digests starch into glucose. Starchy foods that can be easily digested into glucose are critical to the development child for energy and proper growth. This study investigated the use of a noninvasive breath test for the assessment of amylase sufficiency, digestibility of normal and modified sorghum porridges and gastric emptying rate of a sorghum porridge in Malian and U.S. children.
详细描述
The purpose of this research is to test the hypotheses that: 1.) Moderately malnourished stunted children have low pancreatic α-amylase activity; and 2.) Modified starchy food preparations will have better (higher) digestibility than the commonly given foods for both moderately malnourished stunted and healthy non-stunted children. A noninvasive breath test was used to assess amylase insufficiency in moderately malnourished and stunted children in Mali, as well as in healthy children in Mali and the United States. Moderately malnourished and healthy children in Mali were fed sorghum porridges, which are commonly consumed in Mali. Porridges contained a 13C-labeled substrate (algal starch or octanoic acid) for assessment of amylase insufficiency and gastric emptying rate. In a follow-up study, healthy children in the United States were also assessed for amylase sufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stunted weaned children in the age range 18 - 30 months with height-for-age Z-score (HAZ) below -2 (HAZ<-2)
- •Healthy, weaned children 18-30 months of age for study 1
- •Healthy, weaned children up to 5 years old
排除标准
- •Acutely ill and wasted child with weight for height lower than -2 z-score
- •No medical problems other than their malnutrition status
- •No medications
研究组 & 干预措施
Normal sorghum porridge, algal starch
Sorghum porridge with 13C-algal starch
干预措施: Normal sorghum porridge, algal starch (Other)
Normal sorghum porridge, algal dextrins
Sorghum porridge with 13C-algal starch limit dextrins
干预措施: Normal sorghum porridge, algal dextrins (Other)
Normal sorghum porridge, labeled flour
Sorghum porridge with 13C-labeled sorghum flour
干预措施: Normal sorghum porridge, labeled flour (Other)
Modified sorghum porridge, labeled flour
Modified sorghum porridge with 13C-labeled sorghum flour
干预措施: Modified sorghum porridge, labeled flour (Other)
Thinned sorghum porridge, labeled flour
Modified thinned sorghum porridge with 13C-labeled sorghum flour
干预措施: Thinned sorghum porridge, labeled flour (Other)
Modified sorghum porridge, octanoic acid
Modified sorghum porridge with 13C-labeled octanoic acid
干预措施: Modified sorghum porridge, octanoic acid (Other)
结局指标
主要结局
Gastric emptying
时间窗: 3 hours after being fed test meal
Breath test using 13C-tracer in octanoic acid was used to assess gastric emptying in healthy and moderately malnourished children
Alpha-amylase sufficiency in children
时间窗: 3 hours after being fed test meal
Breath test using 13C-tracer was used to assess alpha-amylase sufficiency in healthy and moderately malnourished children
Starch digestibility
时间窗: 3 hours after being fed test meal
Breath test using 13C-tracer in labeled sorghum flour was used to assess starch digestibility of three different prepared sorghum porridges of different thicknesses in healthy and moderately malnourished children
次要结局
未报告次要终点
研究者
Bruce R. Hamaker
Professor
Purdue University