Efficacy of Low Glycemic Index Diet vs Modified Atkins Diet and Gluten Free Casein Free Diet as add-on Therapy With Standard of Care in Children With Autism Spectrum Disorder

Brief summary (registry, in English)

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: 1. Low Glycemic Index diet arm: foods with glycemic index \>50 would be excluded 2. Modified Atkins diet arm: a high-fat, low carbohydrate diet in which carbohydrate intake would be restricted to 10 g/day 3. Gluten-free casein-free diet arm: gluten (oats, barley, wheat, rye) and casein (milk and milk products) containing foods would be excluded 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.

What you commit to

• Study type: Interventional
• Planned participants: 123
• From 1 Sept 2026 to the primary completion date, 1 Jul 2028
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 3 years to 8 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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