Autism & Developmental

The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism.

Hyman et al. (2016) · Journal of autism and developmental disorders 2016
★ The Verdict

A blinded cookie test found gluten and casein did not worsen autism traits, weakening the main reason parents try GFCF.

✓ Read this if BCBAs advising families who ask about special diets for autism.
✗ Skip if Practitioners already convinced by prior negative GFCF trials.

01Research in Context

01

What this study did

Fourteen kids with autism ate a gluten-free, casein-free diet for four weeks. Then they got snack cookies twice a week for six weeks.

Half the cookies held real gluten and casein. Half were placebo. No one knew which was which. Parents, teachers and doctors rated behavior, sleep and bowel patterns after every snack.

02

What they found

Kids acted the same no matter which cookie they ate. Scores for hyperactivity, irritability and language did not budge.

Stool frequency, sleep hours and a urine gut marker also stayed flat. The diet challenge showed zero effect.

03

How this fits with other research

Öztürk et al. (2026) pooled 17 GFCF studies and still call evidence "preliminary." Our 2016 trial is one of the few double-blind tests in their pool, so the weak signal is not surprising.

Esteban-Figuerola et al. (2019) found autistic children already eat less dairy and protein. Removing even more with GFCF could widen those gaps.

Root et al. (2017) ruled out a urine marker once used to justify the diet. Together the three papers undercut both the mechanism and the need for GFCF.

04

Why it matters

You can now tell families that a rigorous challenge found no hidden reaction to gluten or casein. Save your clinical hours for diets that show benefit and watch calcium, vitamin D and protein if parents still wish to go GFCF.

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→ Action — try this Monday

Show parents the graph: no behavior spike after gluten/casein cookies and discuss calcium-rich alternatives if they stay GFCF.

02At a glance

Intervention
other
Design
randomized controlled trial
Sample size
14
Population
autism spectrum disorder
Finding
null

03Original abstract

To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3-5 years, on the diet for 4-6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly snacks that contained gluten, casein, gluten and casein, or placebo. With nutritional counseling, the diet was safe and well-tolerated. However, dietary challenges did not have statistically significant effects on measures of physiologic functioning, behavior problems, or autism symptoms. Although these findings must be interpreted with caution because of the small sample size, the study does not provide evidence to support general use of the GFCF diet.

Journal of autism and developmental disorders, 2016 · doi:10.1007/s10803-015-2564-9