Amino Acid Supplementation in Children with Stunting

NCT06676215 | Not Yet Recruiting DMC

• 1 other identifier: FIERC-2023-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stunted Growth

Keywords

Amino Acid Supplementation; Gut Function; Nutritional Interventions; Stunting; Children Below 3 Years Old

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days

  Baseline and end of intervention at 28 days

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• Change from Baseline in Length-for-age z-score (LAZ) at 28 Days and 6 Months

  Baseline and end of intervention at 28 days and follow-up after 6 months

• Change from Baseline in Weight at 28 days

  Baseline and end of intervention at 28 days

• Change from Baseline in Body Composition in 6 months

  Baseline and follow-up after 6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

complementary food supplemented with indispensable amino acid (IAA) mix

Dietary Supplement: IAA mix supplement; Other: Complementary food comprised of rice and legumes

Control Group

EXPERIMENTAL

complementary food without IAA mix

Other: Complementary food comprised of rice and legumes

Interventions

IAA mix supplement DIETARY_SUPPLEMENT

The intervention is a daily IAA dose that provides x1.5 the estimated average requirement (EAR) for a healthy child. This IAA dose will be mixed to the complementary food and will be taken once daily for 4 weeks (28 days) by the child in the intervention group.

Intervention Arm

Complementary food comprised of rice and legumes OTHER

Each study child will receive standard complementary food which he/she will take once daily for 4 weeks (28 days)

Control Group; Intervention Arm

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Food and Nutrition Research Institute, Philippines: lead
• International Atomic Energy Agency: collaborator
• University of Glasgow: collaborator
• Ghana Atomic Energy Commission: collaborator
• Kamuzu University of Health Sciences: collaborator
• University of Zambia: collaborator
• Rutgers, The State University of New Jersey: collaborator
• St. John's Research Institute: collaborator
• cnesten, Morocco: collaborator

Study Sites (1)

Department of Science and Technology - Food and Nutrition Research Institute

City of Taguig, National Capital Region, 1631, Philippines

Location

Related Publications (52)

• Abtahi S, Sailer A, Roland JT, Haest X, Chanez-Paredes SD, Ahmad K, Sadiq K, Iqbal NT, Ali SA, Turner JR. Intestinal Epithelial Digestive, Transport, and Barrier Protein Expression Is Increased in Environmental Enteric Dysfunction. Lab Invest. 2023 Apr;103(4):100036. doi: 10.1016/j.labinv.2022.100036. Epub 2023 Jan 10.

  PMID: 36870290 BACKGROUND

• Antiporta DA, Ambikapathi R, Bose A, Maciel B, Mahopo TC, Patil C, Turab A, Olortegui MP, Islam M, Bauck A, McCormick B, Caulfield LE; MAL-ED Network Investigators. Micronutrient intake and the probability of nutrient adequacy among children 9-24 months of age: results from the MAL-ED birth cohort study. Public Health Nutr. 2021 Jun;24(9):2592-2602. doi: 10.1017/S1368980020000877. Epub 2020 Jul 2.

  PMID: 32611463 BACKGROUND

• Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.

  PMID: 23996605 BACKGROUND

• Arsenault JE, Brown KH. Effects of protein or amino-acid supplementation on the physical growth of young children in low-income countries. Nutr Rev. 2017 Sep 1;75(9):699-717. doi: 10.1093/nutrit/nux027.

  PMID: 28938793 BACKGROUND

• Budge S, Parker AH, Hutchings PT, Garbutt C. Environmental enteric dysfunction and child stunting. Nutr Rev. 2019 Apr 1;77(4):240-253. doi: 10.1093/nutrit/nuy068.

  PMID: 30753710 BACKGROUND

• Capanzana MV, Aguila DV, Gironella GMP, Montecillo KV. Nutritional status of children ages 0-5 and 5-10 years old in households headed by fisherfolks in the Philippines. Arch Public Health. 2018 Apr 16;76:24. doi: 10.1186/s13690-018-0267-3. eCollection 2018.

  PMID: 29686867 BACKGROUND

• Denno DM, VanBuskirk K, Nelson ZC, Musser CA, Hay Burgess DC, Tarr PI. Use of the lactulose to mannitol ratio to evaluate childhood environmental enteric dysfunction: a systematic review. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S213-9. doi: 10.1093/cid/ciu541.

  PMID: 25305289 BACKGROUND

• Devi S, Varkey A, Sheshshayee MS, Preston T, Kurpad AV. Measurement of protein digestibility in humans by a dual-tracer method. Am J Clin Nutr. 2018 Jun 1;107(6):984-991. doi: 10.1093/ajcn/nqy062.

  PMID: 29771297 BACKGROUND

• Dewey KG, Brown KH. Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs. Food Nutr Bull. 2003 Mar;24(1):5-28. doi: 10.1177/156482650302400102.

  PMID: 12664525 BACKGROUND

• Elango R. Tolerable Upper Intake Level for Individual Amino Acids in Humans: A Narrative Review of Recent Clinical Studies. Adv Nutr. 2023 Jul;14(4):885-894. doi: 10.1016/j.advnut.2023.04.004. Epub 2023 Apr 14.

  PMID: 37062432 BACKGROUND

• Fahim SM, Das S, Sanin KI, Gazi MA, Mahfuz M, Islam MM, Ahmed T. Association of Fecal Markers of Environmental Enteric Dysfunction with Zinc and Iron Status among Children at First Two Years of Life in Bangladesh. Am J Trop Med Hyg. 2018 Aug;99(2):489-494. doi: 10.4269/ajtmh.17-0985. Epub 2018 Jun 7.

  PMID: 29893201 BACKGROUND

• Faubion WA, Camilleri M, Murray JA, Kelly P, Amadi B, Kosek MN, Enders F, Larson J, Grover M, Boe G, Dyer R, Singh R. Improving the detection of environmental enteric dysfunction: a lactulose, rhamnose assay of intestinal permeability in children aged under 5 years exposed to poor sanitation and hygiene. BMJ Glob Health. 2016 Jul 4;1(1):e000066. doi: 10.1136/bmjgh-2016-000066. eCollection 2016.

  PMID: 28588929 BACKGROUND

• Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.

  PMID: 23107551 BACKGROUND

• Gibson RS, Ferguson EL, Lehrfeld J. Complementary foods for infant feeding in developing countries: their nutrient adequacy and improvement. Eur J Clin Nutr. 1998 Oct;52(10):764-70. doi: 10.1038/sj.ejcn.1600645.

  PMID: 9805226 BACKGROUND

• Goron A, Moinard C. Amino acids and sport: a true love story? Amino Acids. 2018 Aug;50(8):969-980. doi: 10.1007/s00726-018-2591-x. Epub 2018 May 31.

  PMID: 29855718 BACKGROUND

• Goto K, Chew F, Torun B, Peerson JM, Brown KH. Epidemiology of altered intestinal permeability to lactulose and mannitol in Guatemalan infants. J Pediatr Gastroenterol Nutr. 1999 Mar;28(3):282-90. doi: 10.1097/00005176-199903000-00013.

  PMID: 10067729 BACKGROUND

• Holecek M. Side effects of amino acid supplements. Physiol Res. 2022 Mar 25;71(1):29-45. doi: 10.33549/physiolres.934790. Epub 2022 Jan 19.

  PMID: 35043647 BACKGROUND

• Koletzko B, Sauerwald T, Demmelmair H. Safety of stable isotope use. Eur J Pediatr. 1997 Aug;156 Suppl 1:S12-7. doi: 10.1007/pl00014267.

  PMID: 9266209 BACKGROUND

• Kosek M, Haque R, Lima A, Babji S, Shrestha S, Qureshi S, Amidou S, Mduma E, Lee G, Yori PP, Guerrant RL, Bhutta Z, Mason C, Kang G, Kabir M, Amour C, Bessong P, Turab A, Seidman J, Olortegui MP, Quetz J, Lang D, Gratz J, Miller M, Gottlieb M. Fecal markers of intestinal inflammation and permeability associated with the subsequent acquisition of linear growth deficits in infants. Am J Trop Med Hyg. 2013 Feb;88(2):390-396. doi: 10.4269/ajtmh.2012.12-0549. Epub 2012 Nov 26.

  PMID: 23185075 BACKGROUND

• Kosek MN, Mduma E, Kosek PS, Lee GO, Svensen E, Pan WKY, Olortegui MP, Bream JH, Patil C, Asayag CR, Sanchez GM, Caulfield LE, Gratz J, Yori PP. Plasma Tryptophan and the Kynurenine-Tryptophan Ratio are Associated with the Acquisition of Statural Growth Deficits and Oral Vaccine Underperformance in Populations with Environmental Enteropathy. Am J Trop Med Hyg. 2016 Oct 5;95(4):928-937. doi: 10.4269/ajtmh.16-0037. Epub 2016 Aug 8.

  PMID: 27503512 BACKGROUND

• Lee G, Pan W, Penataro Yori P, Paredes Olortegui M, Tilley D, Gregory M, Oberhelman R, Burga R, Chavez CB, Kosek M. Symptomatic and asymptomatic Campylobacter infections associated with reduced growth in Peruvian children. PLoS Negl Trop Dis. 2013;7(1):e2036. doi: 10.1371/journal.pntd.0002036. Epub 2013 Jan 31.

  PMID: 23383356 BACKGROUND

• Lee G, Paredes Olortegui M, Penataro Yori P, Black RE, Caulfield L, Banda Chavez C, Hall E, Pan WK, Meza R, Kosek M. Effects of Shigella-, Campylobacter- and ETEC-associated diarrhea on childhood growth. Pediatr Infect Dis J. 2014 Oct;33(10):1004-9. doi: 10.1097/INF.0000000000000351.

  PMID: 25361185 BACKGROUND

• Lee GO, McCormick BJJ, Seidman JC, Kosek MN, Haque R, Olortegui MP, Lima AAM, Bhutta ZA, Kang G, Samie A, Amour C, Mason CJ, Ahmed T, Yori PP, Oliveira DB, Alam D, Babji S, Bessong P, Mduma E, Shrestha SK, Ambikapathi R, Lang DR, Gottlieb M, Guerrant RL, Caulfield LE, For The Mal-Ed Network Investigators. Infant Nutritional Status, Feeding Practices, Enteropathogen Exposure, Socioeconomic Status, and Illness Are Associated with Gut Barrier Function As Assessed by the Lactulose Mannitol Test in the MAL-ED Birth Cohort. Am J Trop Med Hyg. 2017 Jul;97(1):281-290. doi: 10.4269/ajtmh.16-0830.

  PMID: 28719336 BACKGROUND

• Leenders EKSM, de Waard M, van Goudoever JB. Low- versus High-Dose and Early versus Late Parenteral Amino-Acid Administration in Very-Low-Birth-Weight Infants: A Systematic Review and Meta-Analysis. Neonatology. 2018;113(3):187-205. doi: 10.1159/000481192. Epub 2017 Dec 22.

  PMID: 29268262 BACKGROUND

• Lima AA, Brito LF, Ribeiro HB, Martins MC, Lustosa AP, Rocha EM, Lima NL, Monte CM, Guerrant RL. Intestinal barrier function and weight gain in malnourished children taking glutamine supplemented enteral formula. J Pediatr Gastroenterol Nutr. 2005 Jan;40(1):28-35. doi: 10.1097/00005176-200501000-00006.

  PMID: 15625423 BACKGROUND

• Louis-Auguste J, Besa E, Zyambo K, Munkombwe D, Banda R, Banda T, Watson A, Mayneris-Perxachs J, Swann J, Kelly P. Tryptophan, glutamine, leucine, and micronutrient supplementation improves environmental enteropathy in Zambian adults: a randomized controlled trial. Am J Clin Nutr. 2019 Nov 1;110(5):1240-1252. doi: 10.1093/ajcn/nqz189.

  PMID: 31504110 BACKGROUND

• Marles RJ, Barrett ML, Barnes J, Chavez ML, Gardiner P, Ko R, Mahady GB, Low Dog T, Sarma ND, Giancaspro GI, Sharaf M, Griffiths J. United States pharmacopeia safety evaluation of spirulina. Crit Rev Food Sci Nutr. 2011 Aug;51(7):593-604. doi: 10.1080/10408391003721719.

  PMID: 21793723 BACKGROUND

• Martorell R, Khan LK, Schroeder DG. Reversibility of stunting: epidemiological findings in children from developing countries. Eur J Clin Nutr. 1994 Feb;48 Suppl 1:S45-57.

  PMID: 8005090 BACKGROUND

• Mbuya MN, Humphrey JH. Preventing environmental enteric dysfunction through improved water, sanitation and hygiene: an opportunity for stunting reduction in developing countries. Matern Child Nutr. 2016 May;12 Suppl 1(Suppl 1):106-20. doi: 10.1111/mcn.12220. Epub 2015 Nov 6.

  PMID: 26542185 BACKGROUND

• McCormick BJJ, Murray-Kolb LE, Lee GO, Schulze KJ, Ross AC, Bauck A, Lima AAM, Maciel BLL, Kosek MN, Seidman JC, Ambikapathi R, Bose A, John S, Kang G, Turab A, Mduma E, Bessong P, Shrestra SK, Ahmed T, Mahfuz M, Olortegui MP, Bhutta Z, Caulfield LE; MAL-ED Network Investigators. Intestinal permeability and inflammation mediate the association between nutrient density of complementary foods and biochemical measures of micronutrient status in young children: results from the MAL-ED study. Am J Clin Nutr. 2019 Oct 1;110(4):1015-1025. doi: 10.1093/ajcn/nqz151.

  PMID: 31565748 BACKGROUND

• McDonald CM, Manji KP, Gosselin K, Tran H, Liu E, Kisenge R, Aboud S, Fawzi WW, Gewirtz AT, Duggan CP. Elevations in serum anti-flagellin and anti-LPS Igs are related to growth faltering in young Tanzanian children. Am J Clin Nutr. 2016 Jun;103(6):1548-54. doi: 10.3945/ajcn.116.131409. Epub 2016 Apr 27.

  PMID: 27121948 BACKGROUND

• McKay S, Gaudier E, Campbell DI, Prentice AM, Albers R. Environmental enteropathy: new targets for nutritional interventions. Int Health. 2010 Sep;2(3):172-80. doi: 10.1016/j.inhe.2010.07.006.

  PMID: 24037697 BACKGROUND

• Millward DJ, Layman DK, Tome D, Schaafsma G. Protein quality assessment: impact of expanding understanding of protein and amino acid needs for optimal health. Am J Clin Nutr. 2008 May;87(5):1576S-1581S. doi: 10.1093/ajcn/87.5.1576S.

  PMID: 18469291 BACKGROUND

• Owino V, Ahmed T, Freemark M, Kelly P, Loy A, Manary M, Loechl C. Environmental Enteric Dysfunction and Growth Failure/Stunting in Global Child Health. Pediatrics. 2016 Dec;138(6):e20160641. doi: 10.1542/peds.2016-0641. Epub 2016 Nov 4.

  PMID: 27940670 BACKGROUND

• Philpott H, Nandurkar S, Lubel J, Gibson PR. Alternative investigations for irritable bowel syndrome. J Gastroenterol Hepatol. 2013 Jan;28(1):73-7. doi: 10.1111/j.1440-1746.2012.07291.x.

  PMID: 23033865 BACKGROUND

• Platts-Mills JA, Babji S, Bodhidatta L, Gratz J, Haque R, Havt A, McCormick BJ, McGrath M, Olortegui MP, Samie A, Shakoor S, Mondal D, Lima IF, Hariraju D, Rayamajhi BB, Qureshi S, Kabir F, Yori PP, Mufamadi B, Amour C, Carreon JD, Richard SA, Lang D, Bessong P, Mduma E, Ahmed T, Lima AA, Mason CJ, Zaidi AK, Bhutta ZA, Kosek M, Guerrant RL, Gottlieb M, Miller M, Kang G, Houpt ER; MAL-ED Network Investigators. Pathogen-specific burdens of community diarrhoea in developing countries: a multisite birth cohort study (MAL-ED). Lancet Glob Health. 2015 Sep;3(9):e564-75. doi: 10.1016/S2214-109X(15)00151-5. Epub 2015 Jul 19.

  PMID: 26202075 BACKGROUND

• Prendergast AJ, Humphrey JH. The stunting syndrome in developing countries. Paediatr Int Child Health. 2014 Nov;34(4):250-65. doi: 10.1179/2046905514Y.0000000158. Epub 2014 Oct 13.

  PMID: 25310000 BACKGROUND

• Prentice AM, Ward KA, Goldberg GR, Jarjou LM, Moore SE, Fulford AJ, Prentice A. Critical windows for nutritional interventions against stunting. Am J Clin Nutr. 2013 May;97(5):911-8. doi: 10.3945/ajcn.112.052332. Epub 2013 Apr 3.

  PMID: 23553163 BACKGROUND

• Psaki SR, Seidman JC, Miller M, Gottlieb M, Bhutta ZA, Ahmed T, Ahmed AS, Bessong P, John SM, Kang G, Kosek M, Lima A, Shrestha P, Svensen E, Checkley W; MAL-ED Network Investigators. Measuring socioeconomic status in multicountry studies: results from the eight-country MAL-ED study. Popul Health Metr. 2014 Mar 21;12(1):8. doi: 10.1186/1478-7954-12-8.

  PMID: 24656134 BACKGROUND

• Regassa R, Tamiru D, Duguma M, Belachew T. Environmental enteropathy and its association with water sanitation and hygiene in slum areas of Jimma Town Ethiopia. PLoS One. 2023 Jun 23;18(6):e0286866. doi: 10.1371/journal.pone.0286866. eCollection 2023.

  PMID: 37352168 BACKGROUND

• Richard SA, McCormick BJJ, Murray-Kolb LE, Lee GO, Seidman JC, Mahfuz M, Ahmed T, Guerrant RL, Petri WA, Rogawski ET, Houpt E, Kang G, Mduma E, Kosek MN, Lima AAM, Shrestha SK, Chandyo RK, Bhutta Z, Bessong P, Caulfield LE; MAL-ED Network Investigators. Enteric dysfunction and other factors associated with attained size at 5 years: MAL-ED birth cohort study findings. Am J Clin Nutr. 2019 Jul 1;110(1):131-138. doi: 10.1093/ajcn/nqz004.

  PMID: 31127812 BACKGROUND

• Rom O, Liu Y, Liu Z, Zhao Y, Wu J, Ghrayeb A, Villacorta L, Fan Y, Chang L, Wang L, Liu C, Yang D, Song J, Rech JC, Guo Y, Wang H, Zhao G, Liang W, Koike Y, Lu H, Koike T, Hayek T, Pennathur S, Xi C, Wen B, Sun D, Garcia-Barrio MT, Aviram M, Gottlieb E, Mor I, Liu W, Zhang J, Chen YE. Glycine-based treatment ameliorates NAFLD by modulating fatty acid oxidation, glutathione synthesis, and the gut microbiome. Sci Transl Med. 2020 Dec 2;12(572):eaaz2841. doi: 10.1126/scitranslmed.aaz2841.

  PMID: 33268508 BACKGROUND

• Ryan KN, Stephenson KB, Trehan I, Shulman RJ, Thakwalakwa C, Murray E, Maleta K, Manary MJ. Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1507-13.e1. doi: 10.1016/j.cgh.2014.01.024. Epub 2014 Jan 22.

  PMID: 24462483 BACKGROUND

• Sangalang SO, Lemence ALG, Ottong ZJ, Valencia JC, Olaguera M, Canja RJF, Mariano SMF, Prado NO, Ocana RMZ, Singson PAA, Cumagun ML, Liao J, Anglo MVJC, Borgemeister C, Kistemann T. School water, sanitation, and hygiene (WaSH) intervention to improve malnutrition, dehydration, health literacy, and handwashing: a cluster-randomised controlled trial in Metro Manila, Philippines. BMC Public Health. 2022 Nov 7;22(1):2034. doi: 10.1186/s12889-022-14398-w.

  PMID: 36344973 BACKGROUND

• Lee GO, Schillinger R, Shivakumar N, Whyte S, Huq S, Ochieng Konyole S, Chileshe J, Paredes-Olortegui M, Owino V, Yazbeck R, Kosek MN, Kelly P, Morrison D. Optimisation, validation and field applicability of a 13C-sucrose breath test to assess intestinal function in environmental enteropathy among children in resource poor settings: study protocol for a prospective study in Bangladesh, India, Kenya, Jamaica, Peru and Zambia. BMJ Open. 2020 Nov 17;10(11):e035841. doi: 10.1136/bmjopen-2019-035841.

  PMID: 33203623 BACKGROUND

• Shivakumar N, Kashyap S, Jahoor F, Devi S, Preston T, Thomas T, Kurpad AV. The Systemic Availability of Indispensable Amino Acids from Orally Ingested Algal and Legume Protein in Young Children at Risk of Environmental Enteric Dysfunction. Am J Clin Nutr. 2023 Jul;118(1):96-102. doi: 10.1016/j.ajcnut.2023.05.014. Epub 2023 May 11.

  PMID: 37178715 BACKGROUND

• Shivakumar N, Thomas T, Devi S, Jahoor F, Kurpad AV. Free living total energy expenditure in young South Indian children at risk of environmental enteric dysfunction and its relation to faltered linear growth. Eur J Clin Nutr. 2023 May;77(5):532-537. doi: 10.1038/s41430-023-01268-w. Epub 2023 Jan 31.

  PMID: 36720933 BACKGROUND

• Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1.

  PMID: 25411039 BACKGROUND

• Smriga M. International Regulations on Amino Acid Use in Foods and Supplements and Recommendations to Control Their Safety Based on Purity and Quality. J Nutr. 2020 Oct 1;150(Suppl 1):2602S-2605S. doi: 10.1093/jn/nxaa093.

  PMID: 33000158 BACKGROUND

• Terry R, van Wettere WH, Whittaker AL, Herde PJ, Howarth GS. Using the noninvasive (13)C-sucrose breath test to measure intestinal sucrase activity in swine. Comp Med. 2012 Dec;62(6):504-7.

  PMID: 23561884 BACKGROUND

• Trehan I, Kelly P, Shaikh N, Manary MJ. New insights into environmental enteric dysfunction. Arch Dis Child. 2016 Aug;101(8):741-4. doi: 10.1136/archdischild-2015-309534. Epub 2016 Mar 1.

  PMID: 26933151 BACKGROUND

• Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover.

  PMID: 18330140 BACKGROUND

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amster Fei P. Baquiran, BS Chemistry

  Department of Science and Technology Food and Nutrition Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amster Fei P. Baquiran, BS Chemistry

CONTACT

+632 8837 8113; afpbaquiran@gmail.com

Carl Vincent D. Cabanilla, BS Chemistry

CONTACT

+632 8837 8113; cvdcabanilla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Science Research Specialist

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: November 6, 2024
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-10

Locations

PH (1)