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CTRI Number  CTRI/2018/03/012439 [Registered on: 08/03/2018] Trial Registered Prospectively
Last Modified On: 08/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Measuring legume protein (chickpea and yellow pea) digestibility 
Scientific Title of Study   Measuring the digestibility of snacks prepared from extruded chickpea and yellow pea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anura V Kurpad  
Designation  MD PhD FAMS Head Division of Nutrition, Professor of Physiology  
Affiliation  St Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences Sarjapur Road Bangalore
St Johns National Academy of Health Sciences Sarjapur Road Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  08025532037  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anura V Kurpad  
Designation  MD PhD FAMS Head Division of Nutrition, Professor of Physiology  
Affiliation  St Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences Sarjapur Road Bangalore
St Johns National Academy of Health Sciences Sarjapur Road Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  08025532037  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anura V Kurpad  
Designation  MD PhD FAMS Head Division of Nutrition, Professor of Physiology  
Affiliation  St Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences Sarjapur Road Bangalore
St Johns National Academy of Health Sciences Sarjapur Road Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  08025532037  
Fax    
Email  a.kurpad@sjri.res.in  
 
Source of Monetary or Material Support  
Tata Education and Development Trust, c/o Sir Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai-400001. 
 
Primary Sponsor  
Name  Tata Trusts 
Address  World Trade Center 1 26th floor, Cuffe Parade, Mumbai 400 005, India 
Type of Sponsor  Other [A charitable organisation of Tata Group founders,] 
 
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 Anura V Kurpad  St. Johns Medical College and Hospital  Sarjapur Road, Bangalore-560034.
Bangalore
KARNATAKA 
080-49467000

a.kurpad@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. Johns Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children within the age group of 6-11 years who have a mild degree of stunting (-1 to -2 HAZ) and anemia (Hb between 8 and 12 g/dL) will be recruited.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chickpea  Digestibility of chickpea protein will be compared against that of yellow pea protein. 
Comparator Agent  Yellow pea  Digestibility of chickpea protein will be compared against that of yellow pea protein. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Children within the age group of 6-11 years, who have a mild
degree of stunting (-1 to -2 HAZ) and anemia (Hb between 8 and 12 g/dL) will be selected for the study. Those who are resident in the catchment area at the time of inclusion, and whose parents/guardians have signed (or thumb-printed whenever illiterate) the informed consent.
 
 
ExclusionCriteria 
Details  Includes prescription medication or supplement use; a history of
serious illness or complications requiring hospitalization, or who were under acute medical care within the last 3 months; current participation in a sports program or a daily exercise routine of moderate or high intensity; the presence of any other disease that is reported or found on clinical examination; and food allergies.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure the digestibility of chickpea in comparison to yellow pea based food product, in low socioeconomic primary school children.  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/06/2018 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Under-nutrition and related health problems are widespread in India, and food quality, rather than quantity is one of the key issues (1). Many recent meetings of International organizations have addressed major issues pertaining to the dietary protein intake and its bioavailability.  FAO released a Dietary Protein Quality Evaluation Report in 2011 (2), which was a preface to the 2012 WHO technical note on foods for the management of moderate acute malnutrition in children (3). Further to this, an Expert Consultation in October 2013 was held to discuss various stable isotopic based methods to measure protein quality in humans (4). Protein bioavailability is measured from oro-ileal balance studies. Since absorption occurs only in the small intestine and colonic bacteria can recycle nitrogen, it is impossible to measure it non-invasively in humans. Hence, the use of intrinsic labeled protein is the best approach to measure bioavailability of indispensable amino acids (IAA) in humans.

Stable isotope labeled plant protein in the food matrix labels the IAA following the preparation and ingestion. Further, their appearance in the blood gives a unique bioavailability measurement. Use of 13C labeled reference protein, such as casein, or 13C-labeled free amino acids along with labeled test meal, gives a direct measure of the digestion/availability of the protein under testing. Therefore, the present study aim is to utilize non-invasive, precise, fast throughput methods to measure digestibility and utilization of specific plant nutrients, specifically proteins/ amino acids; focusing on legume-based food products, i.e., chickpea and yellow pea, as it is critical to evaluate the digestion and absorption of dietary amino acids from these products. This is particularly important for lysine (which is limiting in the target population’s diets) and methionine (which is potentially limiting in legume protein), and important because the target group could have environmental enteric dysfunction, which could limit digestibility and absorption. 

While it may seem that protein digestibility is simply the oro-fecal balance of ingested protein, fecal protein is largely microbial protein and compositionally bears no resemblance to the array of dietary amino acids remaining undigested at the end of the ileum. Accordingly, digestibility determined at the ileal level, as an oro-ileal balance, is critical for determining amino acid losses of both dietary and endogenous origin. However this is virtually impossible to measure non-invasively in healthy human subjects. Therefore, there is a need to evaluate the term digestibility by using stable isotopically labeled techniques which employs the use of labeled protein in food based matrix.

 
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