Gluten-Free Diet in Children with Autism Spectrum Disorders: A Randomized, Controlled, Single-Blinded Trial
To determine whether a gluten-free diet (GFD) compared with a gluten-containing diet (GD) influences functioning of children with autism spectrum disorders (ASD), we performed a randomized, controlled, single-blinded trial. Sixty-six children (36–69 months) with ASD, within the normal IQ (> 70) range, who had been on a GFD for at least 8 weeks before enrollment were eligible for inclusion. After an 8-week run-in period on a GFD, the GFD group continued this diet and the GD group consumed at least one normal meal containing gluten per day for 6 months. There were no differences between groups in autistic symptoms, maladaptive behaviors, or intellectual abilities after the intervention. A GFD compared with a GD did not affect functioning of children with ASD.
Trial registration ClinicalTrials.gov, number NCT02280746.
KeywordsRandomized controlled trial Autism spectrum disorder Children Gluten
We thank Monika Hodyra, Agata Misiak, Majka Niedzielska, for their help in conducting the assessments; Joanna Rachtan-Janicka for her help with the dietetic consultations, and all the families who participated in this study.
AH and HS initially conceptualized this study. AH, AP, HS, and EP contributed to the study protocol. AP, AH, and RK conducted the study. AP and RK analyzed the data under the supervision of AH and EP. AP, AH, and HS wrote the first draft of the manuscript. All authors contributed to (and agreed upon) the final version. AH and HS are the guarantors for the data.
This work was supported by the Nutricia Foundation research Grant [RG8/2013]. The Foundation had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Compliance with Ethical Standards
Conflict of interest
HS is a member of the Scientific Board of the Nutricia Foundation. HS and AH had academic-associated speaking engagements with Nutricia. AP had participated in the training sponsored by Nutricia. Other co-authors declare no conflicts of interest.
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