The Role of Essential Amino Acid Intake and Intestinal Permeability on Amino Acid Blood Profile and Linear Growth Among Indonesian Children 12-24 Months Living in an Agricultural Area: A Basis for a Food Based Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 主要终点
- Amino acid intake
研究概览
简要总结
This study will be comprised of 2 phases. Phase 1 study is a comparative cross-sectional study which will be conducted among children aged 12-24 months living in agricultural area. A total of 172 healthy children consisted of 86 stunted children (Length for age z-score <-2 Standard deviation) and 86 non-stunted children (Length for age z-score ≥0.5 Standard Deviation) will be recruited. Dietary intake, urine and dried blood spot from finger prick will be collected to assess amino acid intake, intestinal permeability and essential blood amino acid respectively. Qualitative study i.e. focus group discussion (FGD) and market survey will also be implemented. According to the result of phase 1 study, 2 types of food-based approaches will be developed, namely Complementary food recommendations (CFR) and Food multi-mix formula
详细描述
Phase 1 study will recruit a total of 172 healthy children who are matched by sex and age. Aside of being stunted, children must have normal weight for length z-score (not wasted or overweight). Data collection will be performed as follows:
- Dietary intake of the children will be collected by 9 days Estimated Food Record by visiting the respondents house
- Urine will be collected once to measure intestinal permeability profile using Lactulose Mannitol ratio indicator.
- Dried blood spot from finger prick will be collected to essential blood amino acid.
To collect information on locally available and culturally accepted protein rich food sources, series of focus group discussion (FGD) and market survey will also be implemented.
Food-based approaches will be developed according to the information attained from phase 1 study. Problem nutrients that are identified from dietary assessment will be fulfilled through optimization of locally available food by using linear programming approach. Problem nutrients that are not able to be fulfilled by CFR will be use as a basis to develop a Food multi-mix (FMM) formula. Data of intestinal permeability profile will be used to add other locally available food in FMM that are potential to improve intestinal permeability.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stunting group is defined as length for age Z-score (LAZ) <-2.0 SD and non-stunting group as LAZ ≥-0.5 SD
- •Normal weight for length Z-score (WLZ ≥-2 SD to ≤+1 SD)
- •Group matching by age, gender
- •Full term gestation
- •Normal birth weight
- •Living with mother
- •Not suffered from diarrhea at least in the last 1 month (as reported by the mothers)
- •Not suffering from fever during assessment (as measured by the health staff)
- •Not born from diabetic mothers (as reported by the mothers)
排除标准
- •Drink Ultra High Temperature (UHT) milk at least 15 days before urine collection
- •Taking any medication.
- •Had taken non-steroidal anti-inflammatory drugs within two weeks of the study,
- •Taken antibiotics within 4 weeks of the study,
- •Unable to drink the sugar solution
- •Refuse to participate until completion of the study
结局指标
主要结局
Amino acid intake
时间窗: January - February 2020
Amino acid intake will be assessed by estimated food record
Blood amino acid
时间窗: January - April 2020
Essential blood amino acid will be measured from finger prick dried blood spot and will be analyzed using LC-MS/MS
Intestinal Permeability
时间窗: January-April 2020
Intestinal permeability will be measured from urine and will be analyzed using HPLC
次要结局
未报告次要终点
研究者
Nia Novita Wirawan
Assistant Professor
University of Brawijaya