| 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
|
|
|
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. |