Nutritional and Dietary Treatment Study for Children/Adults With Autism

Arizona State University (ASU)

Status and phase: Completed; Phase 2

Conditions: Autism

Treatments: Dietary Supplement: Nutritional and Dietary Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT02059577

NutritionDietAutism

Details and patient eligibility

About

70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.

A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.

Enrollment: 120 patients

Sex: All

Ages: 30 months to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria - Autism Group

1. Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
2. Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
3. Age of 2.5 years to 60 years

Enrollment Criteria - Non-autism Group

1. No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
2. No first-degree relatives of individuals with autism (no siblings or parents)
3. Age of 2.5 years to 60 years -

Exclusion criteria

Exclusion Criteria - Autism Group

1. Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
2. Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Treatment Group

Experimental group

Description:

This group received a combination of nutritional treatments, added sequentially, including vitamins/minerals, essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets.

Treatment:

Dietary Supplement: Nutritional and Dietary Interventions

Non-Treatment Group

No Intervention group

Description:

This group did not have any significant changes in their treatments for 12 months