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CTRI Number  CTRI/2022/04/041946 [Registered on: 19/04/2022] Trial Registered Prospectively
Last Modified On: 13/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Nutrition knowledge on protein in household food decision makers of Maharashtra and Goa  
Scientific Title of Study   Assessment of nutrition knowledge on protein quality and requirement amongst gatekeepers of Maharashtrian and Goan community of India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not Applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Dhananjay Vaidya 
Designation  Student 
Affiliation  Dr BMN College of Homescience 
Address  9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience, Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019

Mumbai
MAHARASHTRA
400019
India 
Phone  9623891925  
Fax    
Email  miss.shru2806@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rupali Sengupta 
Designation  Professor 
Affiliation  Dr BMN College of Homescience 
Address  9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience, Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019

Mumbai
MAHARASHTRA
400019
India 
Phone  9892415789  
Fax    
Email  rupali@bmncollege.com  
 
Details of Contact Person
Public Query
 
Name  Shruti Dhananjay Vaidya 
Designation  Student 
Affiliation  Dr BMN College of Homescience 
Address  9th floor, Department of Clinical nutrition and dietetics, Dr BMN College of Homescience, Plot 338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019

Mumbai
MAHARASHTRA
400019
India 
Phone  9623891925  
Fax    
Email  miss.shru2806@gmail.com  
 
Source of Monetary or Material Support  
Dr BMN College of Home Science 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
Shruti Vaidya  Dr BMN College of Home Science  338, Rafi Ahmed Kidwai Rd, Matunga, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA 
9623891925

miss.shru2806@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SevaMandal Education Societys Institutional Ethical Committee (IEC), Matunga, Mumbai-19  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Household food gatekeepers, having a decision taking capacity of food selection, preparation and purchase for entire family, belonging to Maharashtra and Goa region of India 
 
ExclusionCriteria 
Details  below the age of 30, and above the age of 50, belonging to other states, not a food gatekeeper 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference may be seen in the knowledge scores, attitudes and practices between both groups, Maharashtrian and Goan community  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
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   N/A 
Date of First Enrollment (India)   25/04/2022 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   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)?  

Response - NO
Brief Summary  

Proteins form the building blocks of the human body. Almost the entire mechanism of the different organ systems depends on proteins. The amino acids which form the proteins help body repair cells and make new ones. Therefore, it is critically important for the growth and development in children, teens, and pregnant women. Adequate consumption of dietary protein is required for the maintenance of optimal health during normal growth and aging. Over the past two decades, the potential muscle-related benefits achieved by consuming higher-protein diets have become increasingly clear. (Wolfe, 2012)

Despite greater awareness of how higher-protein diets might be advantageous for muscle mass, many have fear of consuming high protein diet, ending up in protein deficit for a long period of time. Either lack of knowledge, or misconceptions about the protein requirements, quality, functions, sources and its significance, forms a barrier from eating moderate to high protein diets which are needed to meet the daily requirements in Indian adults. This lack of information can give rise to long term protein deficiency or toxicity, and may cause long term health problems and conditions. (Ackerman 2020)

The nutrition of an individual depends on the knowledge and practices followed by him/her and/or the gate keeper of the family the individual belongs to. A gatekeeper is the one who is the decision maker of the house concerning the food choice, cooking, and planning for the house. A gatekeeper could be anyone who has maximum say in the family’s food consumption pattern. Usually in Indian families, the Wife, Mother, or Daughter are identified as the gatekeepers. Hence assessing the nutrition knowledge of the gatekeepers is important to understand current nutritional scenario of the family and may help predict possible outcomes.
 
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