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临床试验/CTRI/2020/04/024512
CTRI/2020/04/024512尚未招募不适用

Comparison of goat milk protein digestibility in adults with and without environmental enteric dysfunction

Wellcome Trust DBT India Alliance1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
The main aim of this study is to compare the protein digestion and amino acid absorption in adults with and without EED.

研究概览

简要总结

Undernutrition persists as a major public health issuethat affects 462 million people world-wide with 165 million children beingstunted and 52 million wasted. Both acute (wasting) and chronicmalnutrition (stunting) are associated with significant health and economicburdens in low and middle-income countries (LMICs). With consistent failure orlow effect sizes observed in nutrient supplementation interventions toalleviate under nutritional status, the impact of a poor environment on growthgained importance. A condition termed environmental entericdysfunction (EED) was identified, akin to tropical enteropathy, with featuresof gut dysfunction such as villous atrophy, disruption of the normal gutmicrobiota, altered gut barrier function, increased local and systemicinflammation, and bacterial translocation, leading to increased intestinalpermeability. As a consequence of the gut abnormality noted, thereis potential for reduced nutrient digestion and absorption that could lead tolow availability of nutrients to meet the body’s demands, which in turninfluences the functionality of the individual. However, there are no studies inhumans demonstrating this reduced digestive and absorptive capacity for nutrientsparticularly in an EED context. There is a lack of consensus on reliablediagnostic tests available for EED, in spite of multiple biomarkers that havebeen proposed and studied that relate to the various domains of EED.The dual sugar absorption test (lactulose with mannitol or rhamnose) is widelyaccepted for the assessment of intestinal permeability, albeit its associated limitations.Therefore, this study aims to first, identify adults with EED using the dualsugar absorption test, second, to determine the absorptive and digestivecapacity of amino acids in these individuals. The absorptive capacity will beassessed by adopting an inert stable amino acid isotope (allo-isoleucine), andthe digestion will be measured using the recently development dual stableisotope tracer technique. The intrinsically 2H labeledgoat milk will be used in the digestion protocol. In addition to this, otherintestinal inflammatory markers in the plasma and feces (plasma kynureninetryptophan ratio [KTR] and fecal neopterin, myeloperoxidase [MPO], alpha-1antitrypsin [AAT]) and pancreatic exocrine function (13C-Mixedtriglyceride [MTG], Fecal Elastase-1[FE-1]) will be assessed andcorrelated with digestion/absorption in the same set of adults, in order toadvance understanding of the interlinked mechanistic pathways proposed in EED. The study is proposed in adults rather than children, as it is invasive in nature where the labeled amino acid will be intravenously infused.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Normal BMI between18.5 to 25 kg/m²; or either normal or low BMI (<18 kg/m2) for the group with EED.

排除标准

  • History of smoking or taking other leisure drugs
  • Consumption of alcohol in the previous 24 hours
  • History of antibiotic usage 4 weeks prior to the study
  • On iron supplementation therapy (3 months)
  • On medication such as NSAID’s, proton pump inhibitors or H2 blockers 2 days prior to and on the study day
  • Participation in any nutritional study in the last 6 months
  • History of food allergy, specifically to milk 8.

结局指标

主要结局

The main aim of this study is to compare the protein digestion and amino acid absorption in adults with and without EED.

时间窗: Digestibility calculation will be performed from 4 time points starting from the 5th hour to 8th hour and will be compared between the adult EED and without EED group

次要结局

  • To compare true ileal indispensable amino acid digestibility of goat milk and allo-isoleucine absorption between adults with and without EED(To compare the digestibility and absorption indices obtained for adults with and without EED to plasma/fecal intestinal inflammatory biomarkers and fecal elastase-1)

研究者

发起方
Wellcome Trust DBT India Alliance
申办方类型
Government funding agency

研究点 (1)

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