Investigating the Effects of Game-Based Exercise and Wheat Germ Extract on Physical Fitness Indicators, Inflammatory–Stress Biomarkers, and Cognitive Function (Concentration and Attention) in Children with Down Syndrome: A Double-Blind Randomized Controlled Trial

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.

Controlled clinical trial with three randomized intervention groups on 60 adolescent boys with Down syndrome

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).

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 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.

Physical fitness indices, inflammatory-stress biomarkers (cortisol/CRP), and cognitive function (concentration and attention)

Participants will be assigned to the four study groups using a block randomization method. The randomization unit is the individual. Stratified randomization will not be used. The random allocation sequence will be generated using statistical software and by an individual independent of the research team prior to the start of participant allocation. After eligibility is confirmed and baseline assessments are completed, each participant will be assigned to one of the four groups based on the randomization sequence. In order to maintain allocation concealment, the randomization sequence will be maintained by an independent individual and will not be made available to the researchers responsible for recruitment and evaluation until each participant is allocated.

This research is designed in a double-blind manner, so that both the participants and the researchers will be unaware of the group allocation (supplement/placebo). The supplement and placebo will be prepared in completely identical packages (in terms of appearance, label and method of consumption) and will be distributed by independent staff of the addiction treatment center who are not involved in other parts of the study.