The Effect of High Selenium Functional Food and Selenium Supplement
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
high selenium functional food
selenium supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Children diagnosed with ASD by a pediatrician, based on DSM-5
- ASD children aged 2-6 years.
- ASD children receiving medical and non-medical therapy.
Exclusion Criteria:
- ASD children who were not at the study site.
- Children with ASD are accompanied by severe congenital abnormalities.
Sites / Locations
- Neny Triana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
HSFF group
Selenium suplemen group
Control group
Arm Description
the group was given high selenium funtion selenium for 3 months
the group was given selenium suplemen
the group was given placebo
Outcomes
Primary Outcome Measures
The change of Developmental level
Developmental level was measured by Autism Treatment Evaluation Cheecklist (ATEC)
Secondary Outcome Measures
The change of GPx level
Gluthation peroxidase is antioxidant that measured in the laboratory using elisa method
The change of IL-1 betha level
IL-1 Betha is pro inflamation that measured in the laboratory using elisa method
The change of IL-6 level
IL-6 is pro inflamation that measured in the laboratory using elisa method
The change of TNF-Alpha level
TNF-Alpha is pro inflamation that measured in the laboratory using elisa method
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05218577
Brief Title
The Effect of High Selenium Functional Food and Selenium Supplement
Official Title
The Effect of High Selenium Functional Food and Selenium Supplement on Developmental Level in Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neny Triana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Intervention group were given HSFF and selenium suplemen, and control group was given placebo.
Masking
ParticipantInvestigator
Masking Description
participant did'n know what they had got. the investigator did'n know group.
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSFF group
Arm Type
Experimental
Arm Description
the group was given high selenium funtion selenium for 3 months
Arm Title
Selenium suplemen group
Arm Type
Experimental
Arm Description
the group was given selenium suplemen
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
the group was given placebo
Intervention Type
Other
Intervention Name(s)
high selenium functional food
Other Intervention Name(s)
HSFF
Intervention Description
HSFF was made from the liver of the cow, that participant could eat HSFF direcly.
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium supplement
Intervention Description
20 microgram/day selenium suppplement powder.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
the placebo mocaf powder
Primary Outcome Measure Information:
Title
The change of Developmental level
Description
Developmental level was measured by Autism Treatment Evaluation Cheecklist (ATEC)
Time Frame
Baseline and 3 month after the intervention
Secondary Outcome Measure Information:
Title
The change of GPx level
Description
Gluthation peroxidase is antioxidant that measured in the laboratory using elisa method
Time Frame
Baseline and 3 month after the intervention
Title
The change of IL-1 betha level
Description
IL-1 Betha is pro inflamation that measured in the laboratory using elisa method
Time Frame
Baseline and 3 month after the intervention
Title
The change of IL-6 level
Description
IL-6 is pro inflamation that measured in the laboratory using elisa method
Time Frame
Baseline and 3 month after the intervention
Title
The change of TNF-Alpha level
Description
TNF-Alpha is pro inflamation that measured in the laboratory using elisa method
Time Frame
Baseline and 3 month after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with ASD by a pediatrician, based on DSM-5
ASD children aged 2-6 years.
ASD children receiving medical and non-medical therapy.
Exclusion Criteria:
ASD children who were not at the study site.
Children with ASD are accompanied by severe congenital abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neny Triana
Organizational Affiliation
STIKES Karya Husada Kediri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neny Triana
City
Kediri
State/Province
Jawa Timur
ZIP/Postal Code
64112
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I did'd have a plan share the date
Citations:
PubMed Identifier
26064157
Citation
Brondino N, Fusar-Poli L, Rocchetti M, Provenzani U, Barale F, Politi P. Complementary and Alternative Therapies for Autism Spectrum Disorder. Evid Based Complement Alternat Med. 2015;2015:258589. doi: 10.1155/2015/258589. Epub 2015 May 7.
Results Reference
result
PubMed Identifier
29763648
Citation
Sharma SR, Gonda X, Tarazi FI. Autism Spectrum Disorder: Classification, diagnosis and therapy. Pharmacol Ther. 2018 Oct;190:91-104. doi: 10.1016/j.pharmthera.2018.05.007. Epub 2018 May 12.
Results Reference
result
PubMed Identifier
26418822
Citation
Lange KW, Hauser J, Reissmann A. Gluten-free and casein-free diets in the therapy of autism. Curr Opin Clin Nutr Metab Care. 2015 Nov;18(6):572-5. doi: 10.1097/MCO.0000000000000228.
Results Reference
result
PubMed Identifier
24082241
Citation
Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.
Results Reference
result
PubMed Identifier
31629288
Citation
Kordulewska NK, Kostyra E, Piskorz-Ogorek K, Moszynska M, Cieslinska A, Fiedorowicz E, Jarmolowska B. Serum cytokine levels in children with spectrum autism disorder: Differences in pro- and anti-inflammatory balance. J Neuroimmunol. 2019 Dec 15;337:577066. doi: 10.1016/j.jneuroim.2019.577066. Epub 2019 Sep 15.
Results Reference
result
PubMed Identifier
29867038
Citation
Siniscalco D, Schultz S, Brigida AL, Antonucci N. Inflammation and Neuro-Immune Dysregulations in Autism Spectrum Disorders. Pharmaceuticals (Basel). 2018 Jun 4;11(2):56. doi: 10.3390/ph11020056.
Results Reference
result
Learn more about this trial
The Effect of High Selenium Functional Food and Selenium Supplement
We'll reach out to this number within 24 hrs