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CTRI Number  CTRI/2019/09/021348 [Registered on: 19/09/2019] Trial Registered Prospectively
Last Modified On: 25/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of finger millet porridge to improve body weight and gut microbiota composition among uncomplicated malnourished children of under five years. 
Scientific Title of Study   Understanding the effect of finger millet based dietary supplementation on anthropometry and gut microbial derangements in uncomplicated severe and moderate acute malnutrition in under 5 children- a multi-centric study 
Trial Acronym  NIl 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeev K Varshney 
Designation  Program Director 
Affiliation  International Crops Research Institute for the Semi-Arid Tropics 
Address  Research Program Director - Genetic gains. Center of Excellence in Genomics & Systems Biology,
Patancheru, ICRISAT, Hyderabad.
Medak
TELANGANA
502324
India 
Phone    
Fax    
Email  R.K.Varshney@cgiar.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev K Varshney 
Designation  Program Director 
Affiliation  International Crops Research Institute for the Semi-Arid Tropics 
Address  Research Program Director - Genetic gains. Center of Excellence in Genomics & Systems Biology,
Patancheru, ICRISAT, Hyderabad.
Medak
TELANGANA
502324
India 
Phone    
Fax    
Email  r.k.varshney@cgiar.org  
 
Details of Contact Person
Public Query
 
Name  DEVARAJ J PARASANNANAVAR 
Designation  SCIENTIST C 
Affiliation  NATIONAL INSTITUTE OF NUTRITION 
Address  CLINICAL EPIDEMIOLOGY DIVISION ICMR-NATIONAL INSTITUTE OF NUTRITION,
JAMAI OSMANIA,TARNAKA HYDERABAD
Hyderabad
TELANGANA
500007
India 
Phone  8074928620  
Fax    
Email  jpdevraj26@gmail.com  
 
Source of Monetary or Material Support  
International Crops Research Institute for the SemiArid Tropics, Patancheru, Hyderabad. 
 
Primary Sponsor  
Name  The International Crops Research Institute for the SemiArid Tropics 
Address  PATANCHERU,HYDERABAD 
Type of Sponsor  Other [INTERNATIONAL RESEARCH ORGANISATION] 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Nutrition  Jamai Osmania, Tarnaka, Hyderabad 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRaja Sriswan M  Government Medical College, Thiruvananthapuram (GMCT)  Ulloor - Akkulam Road (Near SAT Hospital), Medical College Junction Chalakkuzhi, Thiruvananthapuram- 695011
Thiruvananthapuram
KERALA 
9885594388

srishwan@gmail.com 
Dr Mahesh Kumar  ICMR-National Institute of Nutrition   Dept of Clinical Epidemiology, ICMR-National Institute of Nutrition, Jamai Osmania,Tarnaka, Hyderabad. 500007
Hyderabad
TELANGANA 
7893370689

mahidoc@yahoo.com 
Dr Santosh Kumar  Society for Health and Demographic Surveillance (SHDS)  Gol Market, opposite of Suri Municipality office 2nd Floor, Suri, Birbhum, West Bengal, India Pin No: 731101
Birbhum
WEST BENGAL 
9885767609

drsantoshkumar999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Human Ethics committee,Medical College, Thiruvananthapuram  Submittted/Under Review 
NINIEC  Approved 
Society for Health and Demographic Surveillance,  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Finger Millet Porridge  75 grams of the finger millet based intervention will be provided once daily for a period of two months by mixing it with hot water to form a porridge Nutritional composition Finger millet Mix Finger millet 30 g Chickpea (Bengal gram) 15 g Groundnut 15 g Jaggery/Sugar 15 g Total 75 g  
Comparator Agent  Hyderabad Mix  75 grams of the Hyderabad Mix as control intervention will be provided once daily for a period of two months by mixing it with hot water to form a porridge. Nutritional Composition Wheat 30 g Chickpea (Bengal gram) 15 g Groundnut 15 g Jaggery/Sugar 15 g Total 75 g .  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  1.For Severe acute malnutrition (SAM) children, weight-for-height z-score (WHZ) should be less than -3 below the median of the WHO child growth standards
2.For Moderate acute malnutrition (MAM) children, weight-for-height z-score (WHZ) should be between -2 and -3 below the median of the WHO child growth standards
3.For Apparently Healthy (AH) children, weight-for-height z-score (WHZ) should be between -1 and +1 of the median of the WHO child growth standards 
 
ExclusionCriteria 
Details  1.Birth weight less than 2.5 kgs
2.Diagnosed to have any chromosomal syndromes or anomalies
3.History of diarrhea, severe acute respiratory illness (SARI) or any other serious ailment requiring hospital admission within a period of at least four weeks before fecal sample collection
4.Consumed any antibiotics, antacids, probiotics, prebiotics, medications containing alcohol or any other products capable of drastically altering the gut microbiome, within a period of at least four weeks before fecal sample collection
5.Requires use of medication or undergoes any medical procedure for treatment of any infection/condition during the feeding trial or follow up period of up to 6months, that may alter the microbiome profile of the gut

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improved body weight and improved gut microbiota health  Baseline(0 day)
Endpoint (60 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in weight gain  60th day to 120th day  
 
Target Sample Size   Total Sample Size="1800"
Sample Size from India="1800" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/10/2019 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Brief Summary: Undernutrition is not simply caused by lack of nutritious food but also the ability to efficiently assimilate nutrients from diet where the gut microbiota plays a critical role enabling the host to maintain energy balance and overall health. Dysbiosis in the gut microbiota composition are now being causally linked to undernutrition, although current modalities of treatment do not encompass ways to address these challenges.

 Our study employs a modern take on nutritional interventions for the management of severe and moderate acute malnutrition by combining a nutritional and a microbiota targeted intervention not only to deliver sufficient calories but also to improve the gut microbiota composition for sustained health benefits even after cessation of the nutritional therapy.

 We intend to use a finger millet based dietary supplement which is rich in dietary fibers to improve gut microbiome composition and in turn overall energy balance in under 5 years old children with severe and moderate acute malnutrition, in comparison to a high-energy wheat based supplement with a much lower dietary fiber content.

 We will conduct randomised control trials to test the effect of a finger millet based dietary intervention on the gut microbiome and its impact on the nutritional status measured by anthropometry of undernourished children from Anganwadi schools in three different states.

 Both soluble and insoluble/non-digestible dietary fibers have a profound effect on the gut microbiota. Finger millets are a rich source of high-quality beneficial dietary fibers as well as polyphenols with anti-inflammatory properties. Use of finger millets should provide an avenue to correct underlying pathologies of undernutrition and help in establishing a more resilient process of energy assimilation through the harmonious action of microbial and host components in the gut.

 

 

 
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