An interventional study of Low glycemic index diet with standard of care and Modified Atkins diet with standard of care in Autism Spectrum Disorder, sponsored by All India Institute of Medical Sciences. Not yet recruiting at 1 site in India. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by All India Institute of Medical Sciences · Not applicable, Interventional, and Treatment
Autism spectrum disorder (ASD) is a heterogenous, lifelong neurodevelopmental disorder with deficits in social communication and restrictive, repetitive patterns of behavior, with onset in the early developmental period leading to significant impairment in adaptive functioning. With the rising prevalence of ASD and expanding access to early intervention programs, there is a need for more efficacious therapies with a biological basis as additional interventions along with standard of care. The rationale for dietary therapies in autism being, the high rate of GI comorbidities and dysbiosis. Based on evidence from our centre, add-on modified Atkins diet and add-on gluten free, casein-free diet are superior to standard of care alone in improving core deficits (measured by CARS-2 score at 6 months ) in children with ASD. Low glycemic index diet is a comparitively less restricitive diet with better adverse effect profile, with preclinical evidence in ASD. It has been proven to be non inferior to MAD for drug refractory epilepsy, with no clinical trials in ASD. This clinical trial aims to learn if add-on low glycemic index diet works as well as modified Atkins diet and gluten free casein free diet along with standard of care in children aged 3 to 8 years with Autism Spectrum Disorder. The main question it aims to answer is:
In children aged 3 to 8 years with Autism Spectrum Disorder, what is the comparative efficacy of add-on low glycemic index diet versus Modified Atkins diet and Gluten free Casein free diet along with standard of care in reducing the CARS-2 score at 6 months post intervention?
Eligible children aged 3-8 years with ASD will be randomised into three arms:
In all three arms, in addition to diet, standard of care involving behavioural therapy, speech therapy and occupational therapy would be continued.
Baseline investigations would be performed prior to diet initiation, and the diet introduced gradually over a period of 2 weeks. Participants would follow the diet for a period of 6 months, maintaining a dietary log. Weekly telephonic contacts and two monthly physical contacts would be made to ensure compliance and check for any adverse events.
Assessments will be performed at baseline, 3 months and 6 months post intervention in the form of autism severity, behavioral, neurocognitive and sleep assessment.
Children aged 3 to 8 years presenting to pediatric neurology OPD and Autism clinic in the department of Pediatrics, AIIMS, New Delhi, will be screened for eligibility. Those children fulfilling the inclusion and exclusion criteria will be enrolled.
Eligible children will be randomised into three groups. Group I would receive add-on Low Glycemic Index diet (LGIT) with standard of care, Group II would receive add-on Modified Atkins diet (MAD) with standard of care and group III would receive add-on Gluten free casein free (GFCF) diet with standard of care. The process of randomisation will be done by a person who has no role in collecting the baseline variables, applying intervention, data collection or analysis of outcomes. Block randomisation would be performed in 1:1:1 ratio with variable block size using computer generated random numbers. These will be generated by a person not involved in the study.
Allocation concealment: Serially numbered, sealed, identical envelope containing the random allocation will be kept at study site as per allocation sequence.
Blinding : The study will be an open label randomised controlled trial. The individual performing behavioural and neuro-cognitive assessments will be blinded to the group to which the patient is randomised.
Baseline demographic details will be collected and following evaluation will be done at baseline, 3 months and 6 months post intervention:
The above copyrighted scales would be administered using authorized materials obtained through appropriate licensing arrangements.
Standard of care: All three groups will receive standard of care intervention plan, which will be devised individually for each subject, including the following:
Behavioural therapy:
The parents of the children will be called telephonically every week to check for any issues and reinforcement provided to ensure that appropriate therapies as advised are being provided.
Dietary therapy:
During the initial 2 weeks, the following workup will be completed: Baseline nutritional assessment in terms of anthropometry, dietary history with 24-hour dietary recall, estimation of required calorie and protein intake along with understanding of individual food preferences.
A pre-diet workup will be done in the form of ECG, RFT, LFT, CBC, fasting lipid profile, Urine calcium creatinine ratio and USG KUB for nephrocalcinosis. Ferritin and 25-OH Vitamin D3 will also be tested to screen for pre-existing nutritional deficiencies and if so, will be supplemented accordingly.
Group I- LGIT with standard of care arm :
Group II-MAD with standard of care arm :
Group III -GFCF diet with standard of care arm
Follow up protocol
Data collection and Analysis: The data required for the study will be first collected in the predesigned proforma. The collected data will then be transferred to Microsoft excel and analysed using STATA. Data will be checked for normality using Shapiro Wilk. For continuous variables that are normally distributed, the unpaired-t test will be applied and if the data is non- parametric then Mann Whitney U test. For comparison within a group between the paired sample, paired-t test will be applied if the data is parametric and Wilcoxon sign rank test will be applied if the data is non parametric. For assessing the correlation between variables, Pearson correlation coefficient will be used if the data is parametric, else spearman correlation coefficient will be used. Pearson's chi-square test will be used to evaluate differences between independent groups for categorized variables provided all the values in the expected table is >5, else Fisher exact test will be applied if table is 2*2, else Fisher test with 10000 simulations will be applied. ANOVA will be used for group comparisons between the three groups.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 123 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →All India Institute of Medical Sciences is the lead sponsor of 27 studies on the registry; 18 are open to participants now.
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Children aged 3 to 8 years diagnosed with ASD according to DSM -V criteria
Exclusion Criteria:
Exclusion of high glycemic index foods (with Glycemic index \>50), along with standard of care
Other: Low glycemic index diet with standard of care
Modified Atkins diet: A less restrictive version of the ketogenic diet, with standard of care
Other: Modified Atkins diet with standard of care
Exclusion of gluten and casein containing foods, along with standard of care
Other: Gluten free casein free diet with standard of care
Low glycemic index diet would involve the exclusion of foods with medium and high glycemic index (above 50) from the diet. Total carbohydrate intake permitted will be upto 40-60 g/day (or 10% of calorie intake, whichever is lesser). Pre diet workup including CBC, RFT, LFT, fasting lipid profile, ECG, urine calcium : creatinine ratio and 12 lead ECG would be performed prior and diet initiated if normal. Baseline nutritional assessment and anthropometry would be performed. The diet would be introduced gradually over 2 weeks and given for 6 months. Standard of care including speech therapy, behavioural and occupational therapy will be continued throughout the intervention period.
Also known as: LGIT with Standard of Care
Modifed Atkins diet is a less restrictive version of ketogenic diet, which is a high fat, low carbohydrate diet in which carbohydrate content is limited to 10g at initiation. The ketogenic ratio approximates to 1:1 at initiation, with no mandate on a set ratio. There will be no restriction on calories, protein or fluid intake. Baseline nutritional assessment and anthropometry would be performed. Pre diet workup including CBC, RFT, LFT, fasting lipid profile, ECG, urine calcium : creatinine ratio and 12 lead ECG would be performed prior and diet initiated if normal. The diet would be introduced gradually over 2 weeks and given for 6 months. Urine ketones will be measured daily using dipstick. Standard of care including speech therapy, behavioural and occupational therapy will be continued throughout the intervention period.
Also known as: MAD with Standard of Care
Gluten free casein free diet involves exclusion of gluten (wheat, rye, oats and barley) and casein (milk and milk products) containing foods. Baseline nutritional assessment and anthropometry will be performed. Pre diet workup in the form of CBC, RFT, LFT, urine calcium:creatinine ratio, fasting lipid profile, 12 lead ECG and USG KUB will be performed and diet initiated if normal. The diet will be introduced gradually over 2 weeks and continued for 6 months. Standard of care including speech therapy, behavioural and occupational therapy will be continued throughout the intervention period.
Also known as: GFCF diet with Standard of Care
To evaluate the efficacy of add-on LGIT vs MAD and GFCF diet along with standard of care in terms of mean reduction in CARS-2 score, at 6 months post intervention, in children with ASD aged 3-8 years.
Childhood Autism Rating Score (CARS-2) is a validated tool to assess the severity of ASD based on the core symptoms. It is a questionnaire including 15 items, each being scored on a scale from 1(no symptom) to 4 (severe symptom) at intervals of 0.5, which is completed by interviewing the primary caregiver as well as direct observation of the child. The standard version (CARS-ST) is for children less than 6 years or above 6 years with language impairment or with IQ\<80, while the high functioning version (CARS-HF) is for children older than 6 years who are verbally fluent with IQ\>80. The cutoffs for CARS-ST no autism/remission, mild-moderate and severe autsim respectively are 15-29.5, 30-36 and 37 - 60 respectively. Based on expert consensus from an expert elicitation procedure, a change of \>4.5 points is considered clinically relevant, to distinguish between interventions which are merely statistically significant from those which produce meaningful changes in behavioral outcome.
Time frame: Baseline and 6 months
To evaluate the efficacy of add-on MAD vs GFCF diet in addition to standard of care in terms of mean reduction of CARS-2 score, at 6 months post intervention in children with ASD aged 3-8 years
Childhood Autism Rating Score (CARS-2) is a validated tool to assess the severity of ASD based on the core symptoms. It is a questionnaire including 15 items, each being scored on a scale from 1(no symptom) to 4 (severe symptom) at intervals of 0.5, which is completed by interviewing the primary caregiver as well as direct observation of the child. The standard version (CARS-ST) is for children less than 6 years or above 6 years with language impairment or with IQ\<80, while the high functioning version (CARS-HF) is for children older than 6 years who are verbally fluent with IQ\>80. The cutoffs for CARS-ST no autism/remission, mild-moderate and severe autsim respectively are 15-29.5, 30-36 and 37 - 60 respectively. Based on expert consensus from an expert elicitation procedure, a change of \>4.5 points is considered clinically relevant, to distinguish between interventions which are merely statistically significant from those which produce meaningful changes in behavioral outcome.
Time frame: Baseline and 6 months
To compare the change in the cognitive ability as measured by DQ (VABS) , SQ (VSMS) and IQ (MISIC) in children receiving add on LGIT vs MAD and GFCF along with standard of care in children with ASD aged 3-8 years at 3 months and 6 months post initiation
Vineland Adaptive Behavior Scale (VABS) : An interview/report-based scale to assess a child's adaptive functioning in four subdomains, yielding developmental quotient (DQ). Vineland Social Maturity Scale (VSMS) : An observational assessment tool for social and adaptive functioning of children aged 0 to 15 years, covering 8 domains of social functioning, giving social age and social quotient (SQ). Malin's Intelligence Scale for Indian Children (MISIC): An adapted version of the Weschler's Intelligence Scale for Indian children, comprising 6 verbal and 5 performance subtests, yielding verbal, performance and full-scale intelligence quotient (IQ).
Time frame: Baseline, 3 months and 6 months
To compare the quantitative reduction in symptoms of co-morbidities like inattention, hyperactivity, aggression (CBCL) and sleep related abnormalities (CHSQ-SF) in children with ASD in all three arms after follow up for 3 and 6 months.
Child Behavioral Checklist (CBCL): Part of the Achenbach system of empirically based assessment, it is a validated scale for to detect emotional and behavioral issues- internalizing and externalizing subgroups, in children aged 6 to 18 years, involving a parent/youth completed questionnaire. Child Sleep Habit Questionnaire-Short Form (CHSQ-SF): A 23- component, parent completed questionnaire which is a screening test for behavioral sleep problems in children.
Time frame: Baseline, 3 months and 6 months
To assess the compliance in children aged 3-8 years with ASD receiving add-on LGIT, MAD and GFCF diet with standard of care
Compliance to dietary therapy and standard of care will be measured through compliance diary (with diet given, urinary keotnes, behavioral intervention, occupational and speech therapy, pharmacotherapy if any) as well as assessed during weekly telephonic contacts and monthly physical visits.
Time frame: From enrolment to 6 months
To assess the adverse effect profile in children aged 3 - 8 years with ASD receiving add-on LGIT, MAD and GFCF diet with standard of care.
Adverse effects will be monitored for during both weekly telephonic contacts as well as two monthly physical contacts using the diet log.
Time frame: From enrolment to 6 months
Plan to share: Undecided
Start is estimated for Sep 2026; primary completion for Jul 2028, 22 months later.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 22 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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All India Institute of Medical Sciences