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 |
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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
|
|
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
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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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