The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism.
Study Goal
The researchers aimed to determine the safety and efficacy of a gluten-free/casein-free (GFCF) diet in improving physiologic functioning, behavior problems, and autism symptoms in children with autism.
Results Summary
The study found that the GFCF diet was safe and well-tolerated with nutritional counseling, but dietary challenges did not show statistically significant effects on physiologic functioning, behavior problems, or autism symptoms. The findings should be interpreted cautiously due to the small sample size.
Population
14 children with autism, aged 3-5 years.
Effective Dosage
Not specified (dietary challenges delivered via weekly snacks containing gluten, casein, both, or placebo).
Duration
4-6 weeks on the diet, followed by a 12-week challenge study and a 12-week follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
gluten-free/casein-free (GFCF) diet | no change | safety and tolerability | 14 children with autism, age 3-5 years | - | was safe and well-tolerated | #1 |
dietary challenges (gluten, casein, gluten and casein) | no change | measures of physiologic functioning | 14 children with autism, age 3-5 years | no significant change | did not have statistically significant effects | #2 |
dietary challenges (gluten, casein, gluten and casein) | no change | behavior problems | 14 children with autism, age 3-5 years | no significant change | did not have statistically significant effects | #3 |
dietary challenges (gluten, casein, gluten and casein) | no change | autism symptoms | 14 children with autism, age 3-5 years | no significant change | did not have statistically significant effects | #4 |
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.