| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [radhika.madhari@gmail.com].
- 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.
- 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 longâ€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 . |