NCT05218577

The Effect of High Selenium Functional Food and Selenium Supplement

Completed NA Last updated 1 February 2022

What this trial tests

NA trial testing high selenium functional food in Autism Spectrum Disorder in 65 participants. Completed in 24 December 2021.

Timeline

1 January 2021

Primary endpoint
24 December 2021

24 December 2021

Quick facts

Lead sponsor	Neny Triana
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	1 January 2021
Primary completion	24 December 2021
Estimated completion	24 December 2021
Sites	1 location across Indonesia

Drugs / interventions tested

• high selenium functional food
• selenium supplement — full drug profile →
• Placebo

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Neny Triana

Who can join

Adults 2 Months to 6, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The role of selenoproteins in neurodevelopment and neurological function: Implications in autism spectrum disorder.
   Behl S, Mehta S, Pandey MK. · · 2023 · cited 16× · PMID 36969558 · DOI 10.3389/fnmol.2023.1130922