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CTRI Number  CTRI/2024/06/069187 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of amino acid intervention on Environmental Enteric Dysfunction. 
Scientific Title of Study   To measure the protein digestibility and absorption by minimally invasive stable isotope-based methods and to assess the effect of amino acid based intervention on Environmental Enteric Dysfunction. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Anura V Kurpad 
Designation  Professor 
Affiliation  St. John’s Research Institute  
Address  Department of Physiology and Nutrition St. Johns Medical College

Bangalore
KARNATAKA
560034
India 
Phone  08049466321  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarita Devi 
Designation  Lecturer 
Affiliation  St. John’s Research Institute  
Address  Division of Nutrition, St. John’s Research Institute

Bangalore
KARNATAKA
560034
India 
Phone  9986426938  
Fax    
Email  sarita@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Sarita Devi 
Designation  Lecturer 
Affiliation  St. John’s Research Institute  
Address  Division of Nutrition, St. John’s Research Institute

Bangalore
KARNATAKA
560034
India 
Phone  9986426938  
Fax    
Email  sarita@sjri.res.in  
 
Source of Monetary or Material Support  
International Atomic Energy Agency (IAEA), Vienna international center,P0 BOX 100,Pin: A-1400, Vienna Austria 
 
Primary Sponsor  
Name  International Atomic Energy Agency (IAEA) 
Address  International Atomic Energy Agency Vienna International Centre, PO Box 100 A-1400 Vienna, Austria 
Type of Sponsor  Other [International governmental organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarita Devi  St. John’s Medical College and Research Institute,   Room No: 403, Division of Nutrition, St. Johns Medical College
Bangalore
KARNATAKA 		 9986426938

sarita@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC), St. John’s Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers - Stunted but apparently healthy Infants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Food supplemented with IAAs (indispensable or essential amino acids)  Nutraceutical (2H- and 13C- labelled proteins and unlabelled sugars at baseline and endline) as well as standard complementary foods supplemented with IAAs for 28 days 
Comparator Agent  Food without IAAs (indispensable or essential amino acids)  Nutraceutical (2H- and 13C-labelled proteins and unlabelled sugars at baseline and endline) as well as standard complementary foods without IAAs for 28 days 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  36.00 Month(s)
Gender  Both 
Details  Stunted LAZ less than 2SD
Infants with good general health and without any clinical signs of physical disability Parent, carer or guardian able and willing to give written, informed consent 
 
ExclusionCriteria 
Details  Under 18 months old
Over 36 months old
Overweight
Have had diarrhea by self-report in the preceding month
Allergies, intolerances, hypersensitivity, severe anemia, medication use, history of infectious diseases, physical or psychiatric, or surgical intervention 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effects of indispensable amino acid (IAA) supplementation on the change in gut permeability as assessed by the L/R ratio from baseline (day 0) to follow-up (day 28).  Baseline (day 0) and end line (day 28) 
 
Secondary Outcome  
Outcome  TimePoints 
Determine the effects of indispensable amino acid (IAA) supplementation on the change in gut digestive capacity as assessed by the 13C-sucrose breath test (13C-SBT) and to determine the effects of indispensable amino acid (IAA) supplementation on the change in plasma protein absorption index by dual stable isotope test (DSIT) from baseline (day 0) to follow-up (day 28)
 		 Baseline (day 0) and endline (day 28) 
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Environmental enteric dysfunction (EED) refers to an incompletely defined syndrome of inflammation, reduced absorptive capacity, and reduced barrier function in the small intestine. It is widespread among children and adults in low- and middle-income countries. Several factors such as environmental and nutritional deficiencies including chronic infections and other diseases can cause EED. With recent development on stable isotope-based technique to measure protein quality, it was observed that plant-based foods have low protein digestibility of indispensable amino acids (IAAs) in infants from low and middle-income countries (LMICs). This raises yet another important question about EED, which is a major contributor of stunting among these children and has been found to be associated with growth faltering. However, it is not clear if EED could contribute to low digestibility of plant protein in this population. Therefore, there is a need to study and test the applicability of combined minimally invasive stable isotope-based protocols for the protein digestion and absorption in infants and assess the effect of amino acids-based intervention on EED. We aim to study the use of dual stable isotope test (DSIT) for the digestion and absorption of amino acids of mung bean protein in 18-36 months infants (with growth faltering) and to evaluate the use of 13C-Sucrose Breath Test (13C-SBT) to assess nutrient absorption as an indicator of intestinal function in the context of EED. Finally, we also aim to use an amino acid-based intervention on the recommended nutrient intake for this age group, to assess its role in ameliorating EED, and to generate new data on the complex interplay of protein metabolism with EED. This study is a multicentric randomized control trial for a Coordinated Research Project (CRP) titled ‘The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children at Risk of Malnutrition’ including participants from Ghana, India, Malawi, Morocco, Peru, Zambia, and Philippines. Each study site will contribute data from 60 children, for a total of 420 children. The intervention will be provided in coded sachets, distributed as per convenient for local custom to best ensure compliance with a minimum of three supervised feeds per week to ensure supplement is consumed at least periodically by the child and to assess compliance. 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; n=30), or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine, in the intervention group; n=30). The IAA dose to be consumed daily provides x1.5 the EAR for each IAA for children 18-36 months old, based on the FAO requirements.For each participant, tests to be conducted at study enrollment will be spread over two days. Similarly, at the end of the study (day 28), as summarized below. Height & Weight-The first anthropometric measurement will be taken at the screening visit (study day 0), because the child’s weight is needed to calculate the dosage for the 13C-SBT and DSIT tests on days 1 and 2. The second anthropometric assessment will be made on study day 32 (after the intervention period). Questionnaires- Questionnaires will be used to collect demographic and socio-economic information. In addition, questionnaires will be used to assess basic dietary data (dietary diversity). 13C-SBT-On study day, 13C-sucrose breath test will be used to assess intestinal sucrase activity following previously published protocols. Briefly, at the start of the study period (time=0), 13C12-sucrose (0.4mg/kg) will be given with 100mL water followed by breath sample collection into an Exetainer tube every 20mins over 240mins (4hrs). DSIT-First, to complete the DSIT, a single blood sample is collected before the start of the study and the time is noted. A mini meal consisting of a local complementary food will be prepared with a cereal/legume blend containing no milk. Immediately prior to the DSIT, the mini meal for the child will be split into 9 portions (8 to be consumed by the child and 1 to be kept for laboratory analysis). The dual stable isotope tracer mixes of U-13C spirulina (10mg/kg) and 2H-AA mix (1.25mg/kg) will be added separately to each portion. The 9th mini meal potion will be kept for analysis. The sample will be frozen to -80°C, lyophilized, and then ground to fine flour and stored for further analysis. Before the start of the study period (immediately before time=0), two breath samples will be collected about 15min apart (time of collection noted). At the start of the study period (time=0), NaH13CO3 (3?mol/kg) will be added to the prime portion i.e., the first 3 mini meal portions (portions 1-3) together. Subsequently, each mini-meal 4-8 is given at hourly intervals for up to 5hrs. Three further blood samples will be collected at 5, 5½ and 6hrs after the commencement of the study (if possible), or a single blood sample collected at 5hrs will be used. Throughout the DSIT, a breath sample will be collected into an Exetainer tube every 20mins over 360mins (6hrs). L/R-On the study day, the lactulose-rhamnose test (L/R) will be alongside the DSIT test. A single urine sample is collected before the start of the study and the time noted. At the start of the study period (time=0), lactulose (1g) and rhamnose (0.2g) will be given with 100mL water. All urine passed up to 5hrs is collected and pooled and the total volume will be noted. Stool samples–On study day 0 (baseline) and 28 (endline), participant caretakers will be asked to provide a stool sample from their children for the assessment of intestinal inflammation (myeloperoxidase and neopterin). Stool samples will be transported at 2-8°C and immediately stored (-80°C). Blood samples-On study days 0 (baseline) and 28 (endline), venous blood will be collected and immediately centrifuged and stored (-80°C) for the determination of plasma markers of intestinal function (LPSBP and iFABP). Breath 13CO2 will be analyzed by isotope ratio mass spectrometry (IRMS). Urine samples (2mL) are stored (-20°C) for analysis of lactulose:rhamnose ratio (L:R) and glycylsarcosine excretion by GCMS. Blood plasma will be collected and aliquoted for assessment of protein digestive capacity (0.5mL; 13C AA’s, 13C9/13C6 Phe) and inflammatory markers (0.1mL; LPSBP, Myo, Neo, IFABP). In addition, urinary metabolomics will also be performed to assess the effect of intervention on EED (only in Indian site). 
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