| 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
|
|
|
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
|
|
|
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. |