| CTRI Number |
CTRI/2024/11/076395 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [clinical nutrition and dietetics] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gluten and casein free diet to reduce symptoms of autism |
|
Scientific Title of Study
|
Effect of gluten and casein free dietary intervention in reducing symptoms of 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 |
Anuradha Sharma |
| Designation |
Dietitian and P.hd. scholar |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Dietician OPD, Dharmashala Building Ground Floor, Mahatma Gandhi Hospital, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8824471539 |
| Fax |
|
| Email |
dranuradhasharma@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Bansal |
| Designation |
Associate professor and Head, Dept. of Clinical Nutrition and dietetics MGMCH |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Room no. 111,Dhramshala Building
1st Floor,MGUMST
Jaipur
RAJASTHAN
302022
India |
| Phone |
9799999674 |
| Fax |
|
| Email |
drvineetabansal@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineeta Bansal |
| Designation |
Associate professor and Head, Dept. of Clinical Nutrition and dietetics MGMCH |
| Affiliation |
Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur |
| Address |
Room no. 111,Dhramshala Building
1st Floor,MGUMST
Jaipur
RAJASTHAN
302022
India |
| Phone |
9799999674 |
| Fax |
|
| Email |
drvineetabansal@mgumst.org |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI INSTITUTE OF ALLIED HEALTH SCIENCES, MGUMST, Jaipur 302017 |
|
|
Primary Sponsor
|
| Name |
ANURADHA SHARMA |
| Address |
Dietitian OPD, Dharamshala building, Ground Floor, Mahatma Gandhi Hospital, MGUMST, Jaipur |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Vineeta Bansal |
Mahatma Gandhi Occupational Therapy College |
2nd Floor, Mahatma Gandhi Occupational Therapy College, Lal Bahadhur Shastri Block, MGUMST, Jaipur
Jaipur
RAJASTHAN |
9799999674
drvineetabansal@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, MGUMST, JAIPUR |
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 |
Control Group with Nutritional Guidance |
Participants in this group will receive a diet plan created to meet their individual dietary needs based on factors such as age, weight, activity level, and any specific health conditions.
The diet will ensure that participants meet their daily macronutrient (carbohydrates, fats, proteins) and micronutrient (vitamins, minerals) requirements.
Balanced Diet
The diet plan will emphasize a balanced intake of all food groups, including grains, fruits, vegetables, proteins, and dairy or dairy alternatives, without restrictions on gluten or casein.
They will not follow any special dietary restrictions (e.g., avoiding gluten or casein) unless medically required for reasons unrelated to the study.
Advised diet has to be taken by the patient daily for 1 year. |
| Intervention |
Gluten and Casein Free Dietary Intervention |
The intervention will follow a Gluten-Free and Casein-Free (GFCF) Diet, focusing on reducing or eliminating gluten and casein to manage symptoms associated with the study condition.
Liver-Supporting Foods
Include foods known to support liver health such as leafy greens, cruciferous vegetables (broccoli, cauliflower), beets, artichokes, and garlic.
Probiotic-Rich Foods
Emphasize the inclusion of foods that are naturally rich in probiotics, including fermented vegetables (sauerkraut, kimchi), kombucha, and non-dairy yogurt.
Refined Sugar
Avoid all forms of refined sugars to reduce inflammation and promote overall health.
Yeast-Containing Foods
Completely remove or significantly reduce yeast-containing foods such as bread, beer, and foods made with baker’s or brewer’s yeast.
Refined Starches
Limit or eliminate refined starches like white bread, pasta, and processed snacks from the diet. Instead, focus on whole, natural starch alternatives.
Organic Foods
Prioritize organic foods to reduce exposure to pesticides and other chemicals that may impact health.
Artificial Ingredients:
Avoid artificial ingredients including:
Artificial colors: (e.g., red #40, yellow #5)
Trans fats Found in processed foods like margarine, mayonnaise, commercial baked goods, and fried foods.
Partially hydrogenated oils Common in fast foods and packaged goods.
Sweeteners
Only use honey and fruit sugars as sweeteners. Avoid complex sugars and sugar substitutes.
Dietary Restrictions on Sugars, Starches, and Grains:
Exclusion: No complex sugars, starches, or grains, including potatoes and sweet potatoes.
Allowed Foods: Meat, fish, eggs, nuts, seeds, certain beans, and non-starchy vegetables.
Fermented Foods and Non-Dairy Yogurt Include to support gut health.
Limited Grains: If consumed, use grains like quinoa, millet, buckwheat, and amaranth, and ensure they are properly soaked before consumption.
Excluded Grains No rice, corn, or soy products.
Foods to Avoid Based on Specific Compounds
Phenols Avoid foods with high phenol content such as artificial additives (colors, flavors, preservatives).
Salicylates Limit foods like red grapes, apples, berries, almonds, and honey.
Amines Reduce or avoid foods such as bananas, chocolate, red wine, beer, sauerkraut, soy sauce, aged cheeses, meats, and bone broths.
Glutamates: Avoid parmesan cheese, soy sauce, peas, corn, tomatoes, MSG, and related additives.
Oxalates:
Minimize foods high in oxalates, including spinach, beets, and almonds.
Advised diet has to be taken by the patient daily for 1 year. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Autism Spectrum Disorder (ASD) confirmed by a qualified
health care professional.
Age range: Age of 3–15 years
No known food allergies or intolerances
Children with an IQ greater than fifty. |
|
| ExclusionCriteria |
| Details |
Children with IQ less than fifty.
Medical conditions or dietary restrictions that could interfere with the study
outcomes.
In ability to comply with study requirements.
Children having food allergies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nutritional Status
GI symptoms
Diet compliance
Behavioural changes |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nutritional Status
GI symptoms
Diet compliance
Behavioural changes |
6 months |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
15/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Two groups will be made according to the inclusion and Exclusion criteria Group A will receive Gluten and Casein Free diet to check the reductions in symptoms of patients with Autism spectrum Disorder
Group B will receive a standard-of-care diet as recommended
Data will be analyzed with an appropriate statistical tool |