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CTRI Number  CTRI/2023/03/050244 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Product Development, Sensory Evaluation and Food Acceptability Trail]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Nutrient dense (No sugar and Low sugar) take home ration food mixes for complementary feeding 
Scientific Title of Study   Nutrient dense (No sugar and Low sugar) take home ration food mixes for complementary feeding using locally available diverse foods - A comprehensive study on product optimization and effect of food processing on sensorial properties, product acceptability, nutrient retention, bioavailability and shelf-life. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2021-15544   Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhari Srisailam Radhika 
Designation  Scientist-E & HOD 
Affiliation  ICMR- National Institute of Nutrition 
Address  Department of Dietetics ICMR-National Institute of Nutrition, Jamai Osmania PO, Hyderabad 500007, 040-27197421 email:radhika.madhari@gmail.com radhika.ms@icmr.gov.in

Hyderabad
TELANGANA
500007
India 
Phone  9440401160  
Fax    
Email  radhika.madhari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhari Srisailam Radhika 
Designation  Scientist-E & HOD 
Affiliation  ICMR- National Institute of Nutrition 
Address  Department of Dietetics ICMR-National Institute of Nutrition, Jamai Osmania PO, Hyderabad 500007, 040-27197421 email:radhika.madhari@gmail.com radhika.ms@icmr.gov.in

Hyderabad
TELANGANA
500007
India 
Phone  9440401160  
Fax    
Email  radhika.madhari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhari Srisailam Radhika 
Designation  Scientist-E & HOD 
Affiliation  ICMR- National Institute of Nutrition 
Address  Department of Dietetics ICMR-National Institute of Nutrition, Jamai Osmania PO, Hyderabad 500007, 040-27197421 email:radhika.madhari@gmail.com radhika.ms@icmr.gov.in

Hyderabad
TELANGANA
500007
India 
Phone  9440401160  
Fax    
Email  radhika.madhari@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India. 
Type of Sponsor  Government funding agency 
 
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 
DrMSRadhika  ICMR-National Institute of Nutrition  ICMR-National Institute of Nutrition, Jamai Osmania PO, Hyderabad 500007
Hyderabad
TELANGANA 
040-27197421

radhika.madhari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR NIN Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children Below 3 years Sensory Panel age group 20-39 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Existing Take Home Ration(THR) provided by ICDS for complementary feeding in the state of Telangana  THR is prepared from more of cereal and refined sugar with little pulse, diary and health fat 
Intervention  Optimized nutrient dense complementary food mixes  Complementary food mixes will be optimized from locally available food stuffs to maximize nutrient content and acceptable sensory scores 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  30.00 Month(s)
Gender  Both 
Details  All children in the age group of 12-30 months identified as beneficiaries of SNP-ICDS
and their mothers/caregivers.
ï‚· Consuming solid foods for at-least the past 30 days.
Consuming the existing THR products for at least the past 30 days.
Apparently healthy, not presently suffering from acute illness. (fever, ARI etc..,).
No known allergy to milk products, wheat products, nuts etc.
Moderate underweight, stunting and wasting to normal grade children.
 
 
ExclusionCriteria 
Details  Children who are not the beneficiaries of ICDS are excluded.
Children who do not consume the existing THR the past 30 days.
Who are suffering from acute/chronic illness
Who have known allergy to milk products, wheat products, nuts etc.
The members of sensory panel should not be below 20 years and more than 39 years

For adults,
all who do not satisfy the inclusion criteria
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Feasible nutrient dense semi-perishable food formulations with a higher protein quality,
prepared from diverse local foods that are well accepted will be developed for complementary
feeding.
 
0-7 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effects of selected food processing treatments on retention & bioavailability of selected nutrients  from 6 month-14 month 
To test the sensory properties of the child friendly traditional recipes prepared from the food mixes, in an untrained mothers’ panel compared to Balamrutham  from 13th month to 18th month 
To assess the acceptability of the recipes prepared using the optimized formulations in 12–30-month-old ICDS child beneficiaries compared to Balamrutham  from 13th month - 19th month 
To estimate the shelf life of the formulated food mixes compared to the existing Balamrutham  from 14th month to 19th month 
Final Data Management and reporting   from 19th month to 24th month 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 2 
Date of First Enrollment (India)   13/03/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No Publications  
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [radhika.madhari@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Complementary feeding for infants refers to the timely introduction of nutrient-rich foods in addition to breastfeeding and are needed to fill the gap between the total requirements of the child and the amount provided by breast milk. Inadequate intake in this period and beyond can affect growth, development and metabolism, having long‐term health effects . Habitual diets of under 2y old children in India are suboptimal, are of low protein quality, as well as low in healthy fats and micronutrient density, which may have undesirable health impacts. Nutrition specific and nutrition-sensitive interventions during this vulnerable period are required to maximize health benefits, as interventions after this period may have little impact. The Government of India has launched a program called the Integrated Child Development Services (ICDS) under the aegis of Ministry of Women and Child Development (MoWCD), which offers a variety of nutrition and health services to impact the first 1,000 days of life and beyond and is implemented by all the state governments. In the states of Telangana and Andhra Pradesh, a predominantly cereal-based blended flour with little amounts of pulses milk powder and plant-based oil and a very high amount of added free sugars (>20%), is provided to 06-35-month-old children which is supplied as a Take-Home Ration (THR). WHO suggests adults and children to lower their daily consumption of free sugars to less than 10% of their total energy intake for good health and recommends further reduction to less than 10% of total energy, as this would provide improved health benefits. Further, ICMR-NIN updated the Indian food composition tables in 2017 and has more recently published the “Nutrient Requirements for Indians” and also created the “My plate for the Day” in 2020, indicating food-based recommendations in terms of the proportion of foods to be sourced from eight diverse essential food groups to meet the nutrient requirements. In line with these recent developments, we wish to develop nutrient-dense food mixes for complementary feeding, one with no added refined sugar and another with low sugar (5-10% by weight), using locally available foods sourced from diverse food groups and test the effects of food processing on their nutrient content, bio-availability, sensory properties and shelf-life. Further, the acceptability of these formulations will be tested in the target group of 12–24-month-old ICDS children. The active control formulation in this study would be the existing THR . 

 
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