The Effect of High Selenium Functional Food and Selenium Supplement
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The prevalence of ASD is increasing every year. Report data from the Center for Diseases
      Control and Prevention (CDC) 1: 68 in 2016 means that out of 68 children, there is 1 child
      with ASD, while in 2017 it increased by 1: 36, meaning that out of 36 children there is 1
      child with ASD1. ASD in men is 4 times greater than in women. This study used Randomized
      Controlled Clinical Trials (RCT), double blind, 65 research subjects randomized to provide
      intervention for 3 months in group 1 (n = 22) processed beef liver high in selenium, group 2
      (n = 22) supplemented with selenium, group 2 (n = 22) supplemented with selenium, group 1 (n
      = 22) 3 (n=21) control group. Outcome of ATEC score measurement in the three groups. Major
      hypothesis There is a difference in the comparison of giving high selenium functional food
      (HSFF) with selenium supplements to decreasing ATEC scores in Autism Spectrum Disorder (ASD)
      children, increasing levels of the enzyme glutathione peroxidase (GPx), and decreasing IL-β,
      IL-6 and TNF-α . Minor Hypothesis. a. There was a decrease in the ATEC score of ASD children
      in the intervention group of processed beef liver high in selenium, selenium supplementation
      compared to the control group b. The difference in the increase in GPx enzyme levels in the
      intervention group processed beef liver high in selenium, selenium supplementation compared
      to the control group in ASD children. c. Differences in decreased levels of IL-1β in the
      intervention group processed beef liver high in selenium, selenium supplementation compared
      to the control group with ASD.d. Differences in decreased levels of IL-6 in the intervention
      group processed high-selenium beef liver, selenium supplementation compared to the control
      group with ASD children. e. Differences in decreased levels of TNF- in the intervention group
      processed beef liver high in selenium, selenium supplementation compared to the control group
      with ASD children. Participants were randomized into three groups: Intervention group 1 high
      selenium functional food (n=22), Intervention 2 selenium supplement and group 3 control
      (n=21).
    

Detailed description: 
      Introduction:

      Autism Spectrum Disorder (ASD) is a developmental disorder, which is characterized by two
      symptoms, namely, barriers to communication/social interaction and restrictive/repetitive
      behavior. Knowing children with ASD, parents reported their children at the age of 18 months
      with verbal and non-verbal speech delays compared to children their age. To find out as early
      as possible children with ASD, it is necessary to be screened at the age of 18 and 24 months,
      before a diagnosis of ASD is made based on the DSM-5 (Diagnostic and Statistical Manual of
      Mental Disorders-5), this is to conduct early intensive intervention in improving the
      disorder. its development. The prevalence of ASD is increasing every year. Report data from
      the Center for Diseases Control and Prevention (CDC) 1: 68 in 2016 means that out of 68
      children, there is 1 child with ASD, while in 2017 it increased by 1: 36, meaning that out of
      36 children there is 1 child with ASD1. ASD in men is 4 times greater than in women.

      The causes of ASD are non-genetic and genetic. Non genetic include, neuroinflammation and
      neuroimmunity, digestive disorders, neuropathology, heavy metal poisoning. Inflammation of
      the innervation of children with ASD causes the production of pro-inflammatory cytokines to
      increase. Cytokines that play a role in ASD innervation are IL-1 , IL-6 and TNF-α. These
      cytokines can cross the blood-brain barrier, thereby influencing behavior in ASD. Children
      with ASD also experience bacterial abnormalities in their stools. Based on the results of the
      study of bacterial cultures in the feces of children with ASD, significant Bifidobacterium,
      Escherichia coli, Lactobacillus, and Enterococcus bacteria were found. This increase in
      faecal flora indicates intestinal inflammation in ASD children, this causes the blood brain
      barrier to be disrupted, because the intestinal function that provides nutrients to neurons
      is not optimal, thus affecting the work of the nervous system as a trigger for
      neuroinflammation. Heavy metal poisoning, in ASD there was an increase in the concentration
      of Hg in the hair, and there was a significant relationship between lead content in ASD hair
      and the development of verbal communication (p= 0.020). Genetic factors, ± 15% ASD It is
      estimated that 37%-90% of siblings with ASD twins will be at risk of developing ASD in their
      siblings.

      Interprofessional ASD handling involves inter-professional collaboration pediatricians,
      psychologists, nurses, medical rehabilitation, and nutritionists working as a team to help
      families with ASD children. Early treatment before the age of 3 years, highly recommended.
      The goal of ASD treatment is to maximize the child's independence and quality of life by
      minimizing the symptoms of ASD development. Treatment with Complementary and Alternative
      Medicine (CAM) is used for the prevention, cure and promotion of ASD. CAM is divided into
      biological therapies including casein free, gluten free, sugar free (CFGFSF) dietary
      interventions, supplements, and non-biological, including social therapy, hearing integration
      training, sensory integration therapy, drama therapy, dance therapy, acupuncture, massage
      therapy, yoga and animal therapy.

      One of the treatments for CAM with biologic therapy in ASD is selenium supplementation, where
      selenium is essential for specific, non-specific, and antioxidant immune responses. Selenium
      given to ASD, is a selenoprotein element as an essential component of the enzyme glutathione
      peroxidase (GPx). GPx acts to reduce hydrogen peroxide (H₂O₂) to water (H2O), improve
      neuronal degeneration and release reactive oxygen species (ROS) due to oxidative stress.
      Selenium as an antioxidant compound, is a compound that works by donating one electron or
      giving electrons (electron donors) to compounds that are oxidant, so that the activity of
      these oxidant compounds can be inhibited.

      Formulation of the problem:

      Can administration of high selenium functional food (HSFF) reduce ATEC scores in developing
      ASD children, increase GPx, decrease IL-1 , IL-6, and TNF- compared to selenium supplements

      Research purposes:

      Proving the comparison of giving high selenium functional food (HSFF) with supplemental
      selenium (SS) on the clinical development of ASD children, can decreased ATEC score,
      increased GPx, decreased IL-1 , IL-6, and TNF-α.

      Research Hypothesis:

      There is a difference in the comparison of giving high selenium functional food (HSFF) with
      selenium supplements to decreasing ATEC scores in children with Autism Spectrum Disorder
      (ASD), increasing levels of the enzyme glutathione peroxidase (GPx), and decreasing IL-β,
      IL-6 and TNF-α.

      Benefits of research:

      Provides academic benefits in improving pediatric nursing knowledge, the immune system IL-1β,
      IL-6, and TNF-α and GPx antioxidants related to high-slenium beef liver preparations and
      selenium supplements in the development of ASD children.

      Research methods:

      A true experimental study with a randomized controlled group pre-post test design. The
      research subjects were ASD boys and girls (n=65), divided into 3 groups, 22 subjects were
      given processed beef liver high in selenium, 22 subjects were supplemented with selenium, 21
      subjects were controls. The characteristics of the research subjects included age, gender,
      first diagnosed with ASD, knowledge of diet and doctor's therapy. Each group was assessed for
      development by ATEC scores, levels of GPx, IL-1β, IL-6 and TNF-α before and after the
      intervention. The intervention group 1 was given processed beef liver with high selenium, the
      intervention group 2 was given selenium supplementation and group 3 as a control was given
      mocaf flour for 3 months.

      The normality test of the data distribution was carried out by Kolmogorov-Smirnov, to
      determine the results before and after the intervention with the paired, unpaired
      t-parametric test and One Way Anova and the non-parametric Chi-Square test, Kruskal Wallis.
    

Intervention name(s): high selenium functional food; selenium supplement; Placebo
Intervention type(s): Other; Dietary Supplement; Other
Intervention description(s): HSFF was made from the liver of the cow, that participant could eat HSFF direcly.; 20 microgram/day selenium suppplement powder.; the placebo mocaf powder
Other intervention name(s): HSFF
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Intervention group were given HSFF and selenium suplemen, and control group was given placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment