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CTRI Number  CTRI/2025/07/091110 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 21/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Other (Specify) [Dietary Intervention ]  
Study Design  Other 
Public Title of Study   Studying the Effect of Nutrition and Diet on Autism Symptoms in Children (3–10 years) with Autism Spectrum Disorder  
Scientific Title of Study   Nutritional assessment and dietary intervention for children (3- 10 years) with Autism Spectrum Disorder 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhumita Rajendraprasad 
Designation  Dietitian and Research Coordinator 
Affiliation  National Institute of Physical Medicine and Rehabilitation 
Address  Dep. of Nutrition & Dietetics (Room No 603) National Institute of Physical Medicine and Rehabilitation (NIPMR) Kalletumkara, Thrissur

Thrissur
KERALA
680683
India 
Phone  9846127973  
Fax    
Email  madhumitarp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhumita Rajendraprasad 
Designation  Dietitian and Research Coordinator 
Affiliation  National Institute of Physical Medicine and Rehabilitation 
Address  Dept. of Nutrition & Dietetics (Room No 603) National Institute of Physical Medicine and Rehabilitation (NIPMR) Kalletumkara, Thrissur, Kerala, India

Thrissur
KERALA
680683
India 
Phone  9846127973  
Fax    
Email  madhumitarp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpa Jose 
Designation  Associate Professor 
Affiliation  St Teresas College 
Address  Dept of Home Science Science Block St Teresas College Cochin, Kerala, India

Ernakulam
KERALA
682011
India 
Phone  9495428080  
Fax    
Email  shilpajose2017@gmail.com  
 
Source of Monetary or Material Support  
Kerala Social Security Mission Poojappura, Thiruvananthapuram 695012, Kerala, India 
 
Primary Sponsor  
Name  Madhumita Rajendraprasad 
Address  Dietitian and Research Coordinator National Institute of Physical Medicine and Rehabilitation Kalletumkara Thrissur 680683 Kerala 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Kerala Social Security Mission   Poojappura Thiruvananthapuram 695012 Kerala  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Madhumita Rajendraprasad  National institute of Physical Medicine and Rehabilitation (NIPMR)  Dept. of Nutrition and Dietetics National Institute of Physical Medicine and Rehabilitation Kalletumkara
Thrissur
KERALA 
9846127973

madhumitarp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIPMR-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dietary Intervention  It is a prospective interventional study with pre and post measurements. Each participants baseline measurements (pre-intervention data), including ATEC scores, BAMBI scores, and nutritional status and post intervention data will be compared 
Intervention  Dietary Intervention  Tailored dietary intervention based on: 1.Initial nutritional assessment 2.Identification of food intolerances via an elimination diet 3.Development of individualized nutrition plans Duration: 3 months 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children diagnosed with ASD based on ISAA between the age group of 3-10 years
Either gender
Recruited with written informed consent
 
 
ExclusionCriteria 
Details  Diagnosis of Asperger syndrome, Rett syndrome or any other congenital disease
Chronic seizures or an acute or chronic affective disease during the past three months

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change in ATEC score (total and domain-wise) before and after 3 months of dietary intervention.
 
1. Time Points: Baseline and 3 months post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in BAMBI scores indicating mealtime behavior improvement.
2. Incidence and pattern of food intolerances and ARFID among enrolled children.
3. Correlation between food intolerances and autism symptom severity (based on ATEC domains).


 
1. Time Points: Baseline and 3 months post-intervention
2. Time Point: Assessed at baseline (during initial dietary evaluation)
3. Time Point: Post-correlation analysis between baseline intolerance data and ATEC scores.
 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   04/08/2025 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This prospective interventional study aims to evaluate the impact of tailored dietary interventions on autism symptomatology and nutritional status in children aged 3 to 10 years diagnosed with Autism Spectrum Disorder. A total of 110 children will be enrolled. At baseline, participants will undergo comprehensive assessments, including anthropometric measurements, dietary intake analysis, biochemical parameters, and a clinical evaluation, to determine their nutritional status. Autism related behaviors will be assessed using standardized tools, such as the Autism Treatment Evaluation Checklist (ATEC) and the Brief Autism Mealtime Behavior Inventory (BAMBI). Food intolerances will be identified using an elimination diet approach, and individualized nutrition plans will be developed based on these findings. The intervention will be implemented over a period of 3 months after which post-intervention assessments will be conducted. The primary outcome is the change in ATEC scores before and after the dietary intervention reflecting the effect of nutrition on autism symptomatology. Secondary outcomes include changes in BAMBI scores, improvements in nutritional status, dietary adequacy, the incidence of Avoidant Restrictive Food Intake Disorder ARFID, and correlations between food intolerances and autism severity. Findings from the study aim to establish evidence based dietary strategies for children with ASD and promote knowledge transfer to caregivers and the broader community enabling sustainable nutrition management and improved quality of life.


 
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