Efficacy of Amino Acid Supplementation on Gut Function and Nutritional Status in FIlipino Children Below Three Years Old
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days
研究概览
简要总结
The goal of this intervention study is to determine the effects of indispensable amino acid (IAA) supplementation on children of either sex, aged 18 to 36 months. The main questions it aims to answer are:
- Does IAA supplementation affect biomarkers of Environmental Enteric Dysfunction (EED), through the Dual Sugar Lactulose/Rhamnose (L/R) test, plasma intestinal fatty acid binding protein, plasma lipopolysaccharide binding protein, fecal myeloperoxidase, fecal neopterin, and gut microbiota?
- Does IAA supplementation impact amino acid digestion, as assessed by a dual-stable isotope tracer?
- What is the weight gain and the changes in length-for-Age z-scores (LAZ) and body composition?
The researchers will compare the effects of consumption of standard complementary food with added IAA against a control group that has no added IAA through the assessment of the various biomarkers.
Participants will:
- answer questions regarding personal, demographic, anthropometric, and food intake information.
- provide biological samples, including breath, urine, stool, blood, and saliva.
- consume solutions or meals that contain sugars and/or stable isotope tracers.
- visit the FNRI and receive house visits by study staff.
- consume complementary food with or without supplement daily for 28 days.
详细描述
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive the standard complementary foods (in the control group) or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (in the intervention group).
Standard complementary foods will be comprised of ingredients mainly of rice and legumes. Standard complementary foods are foods that meet the dietary needs of children 6-36 months of age.
At least three observed (controlled) feeding sessions per week will be conducted over the 4 weeks of the study to confirm that the entire supplement was consumed or confirm intake. The observed feeding will take place at the child's home or at the barangay center. Uptake on non-observed days will be based on the caregiver's report. On each intervention monitoring day, a questionnaire will also be administered to assess child morbidity that day and on the day prior. A pediatrician or an alternate medical practitioner will also be invited during the data collection where in stable isotopes will be administered. The duties and responsibilities of the physician include: medical assessment of the participant, assistance in the collection of blood samples, assessment of adverse events (if any), and provision of first aid (if needed).
In the absence of treatment delays due to adverse events, the intervention will continue for 1 month or until one of the following criteria apply:
- Child is not able to tolerate the supplement (throws up)
- Severe acute malnutrition (SAM)
- Inter-current illness that prevents further administration of treatment
- Unacceptable adverse event(s)
- Study participant voluntarily withdraws from treatment OR
- Other general or specific changes in the study participant's condition render the study participant unacceptable for further treatment in the judgment of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 36 months old (of either sex)
- •Stunted (LAZ of less than -2)
- •Parent, caregiver or guardian able and willing to give written, informed consent
排除标准
- •Wasted (WHZ of less than -2)
- •Overweight (WHZ of more than 2)
- •Have had diarrhea (by self-report) in the preceding month
- •Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
- •Have taken antibiotics in the preceding month
- •Have food allergies/intolerance
- •Had a serious illness within the last three (3) months or have any underlying condition which in the opinion of the pediatrician would put the subject at undue risk of failing study completion or would interfere with analysis of study results
结局指标
主要结局
Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days
时间窗: Baseline and end of intervention at 28 days
次要结局
- Change from Baseline in Protein Absorption as Assessed by the Dual Stable Isotope Tracer (DSIT) Technique at 28 days(Baseline and end of intervention at 28 days)
- Change from Baseline in Gut Digestive Capacity Measured by the 13C-Sucrose Breath Test (SBT) at 28 days(Baseline and end of intervention at 28 days)
- Change from Baseline in Gut Function Based on Plasma LPS-Binding Protein (LPSBP) Concentration at 28 days(Baseline and end of intervention at 28 days)
- Change from Baseline in Gut Function Based on Intestinal Fatty Acid Binding Protein (iFABP) Concentration at 28 days(Baseline and end of intervention at 28 days)
- Change from Baseline in Gut Inflammation Based on Fecal Myeloperoxidase Concentration at 28 days(Baseline and end of intervention at 28 days)
- Change from Baseline in Gut Inflammation Based on Fecal Neopterin Concentration at 28 days(Baseline and end of intervention at 28 days)
研究者
Amster Fei Baquiran
Senior Science Research Specialist
Food and Nutrition Research Institute, Philippines