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Study aim:
This study was designed to investigate the effect of 8 weeks of game-based training and wheat germ extract on physical fitness indices, inflammatory-stress biomarkers, and cognitive function (concentration and attention) in children with Down syndrome.
Design:
Controlled clinical trial with three randomized intervention groups on 60 adolescent boys with Down syndrome
Settings and conduct:
Male adolescents with Down syndrome at the Ali Ibn Abi Taleb Center in Kermanshah, if eligible, will be enrolled in the study and divided into 4 groups. This study is designed as a double-blind study, with both participants and researchers unaware of group allocation (supplement/placebo).
Participants/Inclusion and exclusion criteria:
Inclusion criteria: Genetic confirmation of Down syndrome diagnosis, absence of severe cardiorespiratory diseases, to ensure the absence of underlying cardiovascular diseases, the following will be applied: careful screening with a complete medical history and physical examination by a pediatrician, ability to perform basic movements, negative celiac test in children
Inclusion criteria: unwillingness to participate in the study, occurrence of any sports injury, inability to complete the steps of the sports protocol
Intervention groups:
Intervention group 1: 8 weeks of game-based training (3 sessions per week, 40 minutes each session) + 2.5 grams of NBS supplement daily.
Intervention group 2:8 weeks of game-based training (3 sessions per week, 40 minutes each session) + 2.5 grams of placebo (potato starch) daily.
Intervention group 3: 2.5 grams of NBS supplement daily for 8 weeks.
Control group: 2.5 grams of placebo (potato starch) daily for 8 weeks.
Main outcome variables:
Physical fitness indices, inflammatory-stress biomarkers (cortisol/CRP), and cognitive function (concentration and attention)