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CTRI Number  CTRI/2016/12/007564 [Registered on: 13/12/2016] Trial Registered Prospectively
Last Modified On: 12/12/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Pilot study to optimize the level of protein in products for Indian primary school children 
Scientific Title of Study   Pilot study to optimize the level of protein in products for Indian primary school children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maria Pauline 
Designation  Associate Professor 
Affiliation  St. Johns National Academy of health sciences 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  9844269436  
Fax    
Email  mariapaulinejoe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maria Pauline 
Designation  Associate Professor 
Affiliation  St. Johns National Academy of health sciences 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  9844269436  
Fax    
Email  mariapaulinejoe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maria Pauline 
Designation  Associate Professor 
Affiliation  St. Johns National Academy of health sciences 
Address  Dept. of Physiology St. John’s Medical College, Bangalore, Karnataka , India

Bangalore
KARNATAKA
560034
India 
Phone  9844269436  
Fax    
Email  mariapaulinejoe@gmail.com  
 
Source of Monetary or Material Support  
Jamsetji Tata Trust 
 
Primary Sponsor  
Name  Jamsetji Tata Trust 
Address  Bombay House,24 Homi Mody Street Mumbai 400001 
Type of Sponsor  Other [Trust] 
 
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 Maria Pauline  St. Johns Research Institute  Division of Nutrition, St Johns Research Institute, St. John’s National Academy of Health Sciences, Bangalore-560034 Bangalore KARNATAKA
Bangalore
KARNATAKA 
9844269436

mariapaulinejoe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Indian children of both genders in the age group 6 to 10 years.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A legume based micronutrient-supplemented product containing 06g Protein  Same legume base Micronutrient-supplemented product fortified with 06g protein 2 times per day (Mid morning and post lunch)for 30 days. 
Intervention  A legume based micronutrient-supplemented product containing 08g Protein  Same legume base Micronutrient-supplemented product fortified with 08g protein 2 times per day (Mid morning and post lunch)for 30 days. 
Intervention  A legume based micronutrient-supplemented product containing 10g Protein  Same legume base Micronutrient-supplemented product fortified with 10g protein 2 times per day (Mid morning and post lunch)for 30 days. 
Intervention  A legume based micronutrient-supplemented product containing 12g Protein  A legume base Micronutrient-supplemented product fortified with 12g protein 2 times per day (Mid morning and post lunch)for 30 days. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Parents willing to give an informed consent and subjects willing to give assent.
2.Boys and girls aged between 6-10 years.
3.Children with Z-scores of less than -2.0.
4.Mildly anemic (Hb<12 g/dL).
 
 
ExclusionCriteria 
Details  1.Recent history (3 months) of serious infections, injuries and/ or surgeries.
2.Use of any prescription medications.
3.Children consuming nutritional supplements and/ or health food drinks on a regular basis.
4.Food allergies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference
2.Intestinal microbiota stool sample
3.Serum, urine metabolomics  
Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration. 
 
Secondary Outcome  
Outcome  TimePoints 
Micronutrient status: Hb, Serum folate, B12, ferritin, plasma iron, plasma zinc, renal and liver function test  Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/12/2016 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   "NONE YET" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Under nutrition is responsible for ~35% of deaths in children under 5 years of age1. Long term childhood malnutrition is associated with reduced height achieved in adulthood as well as increased risk of chronic disease2. This study aims to develop affordable and sustainable sources of food products and supplements that will improve growth parameters of children from diverse socioeconomic backgrounds.

Though intense efforts are going on to develop affordable healthy foods to improve nutritional status of growing children, high inter-individual variations in genetic background, access to health care, living conditions, amongst others can make the use of longer-term outcomes such as growth parameters challenging3,4. Changes in the profile of metabolic intermediates and other signaling molecules can provide an earlier read-out of the effects of nutritional interventions in such a setting. Though a few previous studies have examined protein and lipid kinetics in malnourished children, till date only Bartz et al have systematically analyzed this through the effect of in-patient milk-based formulations and out-patient supplementation with ready-to-use therapeutic food (RUTF) on children with severe acute malnutrition (SAM) by targeted and non-targeted metabolomic analysis.

As there is a dearth of studies assessing early and accurate markers of the effect of nutritional formulations on growing children, we propose to rapidly assess the systemic effects of novel food products on the growth of stunted but otherwise healthy primary school children through changes in the metabolome and the microbiome. Such markers can then be utilized in the future for testing efficacy of a variety of nutritional formulations for selecting the most effective, affordable and sustainable ones.

 
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