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CTRI Number  CTRI/2021/06/034006 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On: 03/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Protein Absorption in Adults 
Scientific Title of Study   Assessment of peptide and amino acid absorption in adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
There is no secondary ID  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Anura V Kurpad 
Designation  Professor 
Affiliation  St John’s Medical College 
Address  St. Johns National Academy of Health Sciences, Sarjapura Road
3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences
Bangalore
KARNATAKA
560034
India 
Phone  9686512233  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirupama Shivakumar 
Designation  Clinical Research Fellow 
Affiliation  St. Johns Research Institute 
Address  St. Johns National Academy of Health Sciences, Sarjapura Road
3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences
Bangalore
KARNATAKA
560034
India 
Phone  9900070008  
Fax    
Email  nirupama.s@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nirupama Shivakumar 
Designation  Clinical Research Fellow 
Affiliation  St. Johns Research Institute 
Address  St. Johns National Academy of Health Sciences, Sarjapura Road
3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences
Bangalore
KARNATAKA
560034
India 
Phone  9900070008  
Fax    
Email  nirupama.s@sjri.res.in  
 
Source of Monetary or Material Support  
Queen Mary University of London Global Challenge Research Fund 
 
Primary Sponsor  
Name  Queen Mary University of London Global Challenge Research Fund 
Address  Mile End Road, London E1 4NS 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Zambia
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirupama Shivakumar  St. Johns Research Institute  3rd floor, Division of Nutrition, Department of Physiology, Robert Koch Building, St. John’s Medical College, St. John’s National Academy of health sciences
Bangalore
KARNATAKA 
9900070008

nirupama.s@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee St. Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult healthy volunteers, mainly staff of St. John’s Medical College and Research Institute, and their known contacts, in the age range of 18 to 35 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Normal BMI between18.5 to 25 Kg/m² 
 
ExclusionCriteria 
Details  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

· Diagnosed with chronic medical or surgical illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine associations between uptake of C6, 15N allo-isoleucine or uptake of dipeptide Gly-Sar with lactulose-rhamnose ratio and pro inflammatory markers in stool and plasma.  Outcome will be assessed only on the experiment day, so only one time point.  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="6" 
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   N/A 
Date of First Enrollment (India)   15/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/06/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publications 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Environmental Enteropathy (EE) is a global disorder which contributes to poor child growth, micronutrient deficiencies, and impaired responses to oral vaccines. There is evidence that EE is associated with malabsorption of zinc, but the effects on other intestinal functions are unknown. The principal function of the intestine is to digest and absorb nutrients from the luminal stream, and several biochemical processes are essential to this dominant function. These processes include digestion of proteins into amino acids and dipeptides, digestion of complex carbohydrates into monosaccharides, emulsification and digestion of lipids. Nutrients, including these macronutrients together with micronutrients such as elements and vitamins, are absorbed by epithelial cells using a very complex array of several hundred transporters. A considerable amount of research was carried out on nutrient digestion and absorption in the 1960s and 1970s, but much less has been done recently. Recent elucidation of the importance of EE in global health and nutrition has highlighted the lack of information on digestion and absorption in the world literature, and there is almost no information on the impairments of digestion and absorption related to EE in adults and children in low and middle income countries.

A clinical study of the 13C sucrose breath test (13C-SBT) and the 13C mixed chain triglyceride test (13C-MCTT), was conducted by Paul Kelly and colleagues (collaborating team). The results of the SBT show useful correlation between 13CO2 in breath and three measures of intestinal dysfunction: villus height and surface area, mucosal sucrose-isomaltase expression by immunostaining, and sucrose activity measured ex vivo in biopsies. However, this test only measures mucosal disaccharidase activity. We now want to go on and find tests for other aspects of mucosal digestive/absorptive function.

The significance of this study is that impairments of digestive and absorptive function can be overcome, by using enzymatic supplements, by using specially modified feeds, and/or by providing additional specific nutrients to overcome absorptive defects. While we are developing these tests in adults, the longer term objective is to adapt them for use in children with growth faltering, and to define nutritional modifications which these children may need.

 
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