Dates as a Functional Food for Autism

Summary

Autism spectrum disorder (ASD) is a lifelong developmental disability that includes deficits in social communication and social interaction and restricted, repetitive patterns of behavior, interests, or activities.

The current treatment approaches for the management of autism are expensive, showing unwanted adverse effects; alter the genetic and metabolic pathways. Many studies referred to the importance of probiotics, minerals and antioxidant supplementation in the treatment of accompanied eating and feeding problems. Meanwhile, there are still controversial results about the effectiveness of dietary interventions for ASD like the gluten-free/casein-free diet and the ketogenic diet.

Dates have been documented in the Holy Quran and proved in modern scientific literature to act as potent antioxidants and as an anti-inflammatory, provide a suitable alternative therapy in various diseases cure.

The medicinal therapeutic value of date fruits as nutritional probiotic and its implications in controlling autism through the anti-oxidant effect will be evaluated. Moreover, at which dose Dates fruit can exert its effect and whether this effect is sustained or not will be also evaluated. Besides, Dates' effect on cognitive, neurological parameters, eating behaviors, and gastrointestinal symptoms and anthropometric measures will be evaluated. A non-randomized clinical study on 120 diagnosed autistic children aged 3-12 years in Cairo will be conducted. Participants will be randomly assigned to one of three groups (each with 40 children) receiving one of three regimens; the first group will receive 3 Dates per day for 3 months and the second group will receive 5 Dates per day for 3 months and the third group will receive nothing. All groups will receive nutrition guidance, behavioral modification, and stimulation sessions. Stools and blood samples will be collected before the study, after 12 weeks of the intervention and then 12 weeks after completion of the intervention. Evaluating Dates' ability to decrease the oxidative stress will be done through comparing blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1) and superoxide dismutase (SOD) in children with autism for the three proposed regimen. The impact of the Dates fruit consumption on the microbiota of the autistic children both the pathogenic bacteria and probiotics will be done through traditional stool analysis and Real-time PCR before and after interventions.

Conditions

• Autistic Spectrum Disorder

Interventions

OTHER

Dates fruit as functional Food

Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment

BEHAVIORAL

behavioral modification and stimulation

Behavioral modification applied to the autistic children that is based on applied behavior analysis (ABA), a widely accepted approach that tracks a child's progress in improving his or her skills. We use Positive Behavioral and Support (PBS)

OTHER

nutritional Guidance

The nutritional education sessions are based on educating parents on providing their autistic children with a nutritious, balanced diet. Because children with ASD often have restricted diets as well as difficulty sitting through meal times, they may not be getting all the nutrients they need, particularly calcium and protein

Sponsors & Collaborators

• National Research Centre, Egypt

  lead OTHER

Principal Investigators

• Ammal M Metwally, PhD · National Research Centre, Egypt

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-15

Primary Completion

2022-01-15

Completion

2022-04-15

Countries

• Egypt

Study Locations