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IRCT20141228020465N9 IRCT 2026-09-14 Ayatollah Boroujerdi University The Effects of Game-Based Exercise and Wheat Germ Extract on Physical Fitness, Inflammation, Stress, and Cognitive Function in Children with Down Syndrome 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 2026-10-10 anticipated 60 Complete https://irct.ir/trial/92851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: 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, Blinding description: 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. N/A Down syndrome. Intervention 1: Intervention group 1: Game-based training + wheat germ extract. Subjects will participate in game-based training for 8 weeks. The training program will consist of three sessions per week, each session lasting 40 minutes. Each session will consist of a 5-minute warm-up, 30 minutes of game-based training, and a 5-minute cool-down. Game-based training will include aerobic, strength, balance, and coordination activities in the form of games appropriate to the children’s abilities. At the same time, subjects will receive 2.5 grams of NBS Superfood supplement containing wheat germ extract orally and dissolved in water daily. The supplement will be provided by NBS Superfood (NBS Organic Company, Turkey). Intervention 2: Intervention Group 2: Game-based training + placebo. Subjects will participate in game-based training for 8 weeks. The training program will consist of three sessions per week, each session lasting 40 minutes, including a 5-minute warm-up, 30 minutes of game-based training, and a 5-minute cool-down. The training will include aerobic, strength, balance, and coordination activities in the form of games appropriate to the children's abilities. At the same time, subjects will receive 2.5 grams of placebo (potato starch) daily orally and dissolved in water. Intervention 3: Intervention Group 3: No training + wheat germ extract. Subjects will receive 2.5 grams of NBS Superfood supplement containing wheat germ extract orally and dissolved in water daily for 8 weeks. The supplement will be provided by NBS Superfood (NBS Organic Company, Turkey). Intervention 4: Control group: No training + placebo. Subjects will receive 2.5 grams of placebo (potato starch) orally dissolved in water daily for 8 weeks. This group will not participate in any exercise program and will continue their usual lifestyle during the study period. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet.
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Bourujerd Iran (Islamic Republic of) 69199-69737 +98 66 4246 8320 K_negin_69@yahoo.com University of Ayatollah Boroujerdi Iran (Islamic Republic of) Genetic confirmation of Down syndrome diagnosis Absence of severe cardiorespiratory diseases Ability to perform basic movements Negative celiac test 12 years 16 years Male Unwillingness to participate in the study Occurrence of any sports injury Inability to complete the exercise protocol steps Q90.0 Down syndrome Lifestyle Lifestyle Lifestyle N/A Intervention group 1: Game-based training + wheat germ extract. Subjects will participate in game-based training for 8 weeks. The training program will consist of three sessions per week, each session lasting 40 minutes. Each session will consist of a 5-minute warm-up, 30 minutes of game-based training, and a 5-minute cool-down. Game-based training will include aerobic, strength, balance, and coordination activities in the form of games appropriate to the children’s abilities. At the same time, subjects will receive 2.5 grams of NBS Superfood supplement containing wheat germ extract orally and dissolved in water daily. The supplement will be provided by NBS Superfood (NBS Organic Company, Turkey). Intervention Group 2: Game-based training + placebo. Subjects will participate in game-based training for 8 weeks. The training program will consist of three sessions per week, each session lasting 40 minutes, including a 5-minute warm-up, 30 minutes of game-based training, and a 5-minute cool-down. The training will include aerobic, strength, balance, and coordination activities in the form of games appropriate to the children's abilities. At the same time, subjects will receive 2.5 grams of placebo (potato starch) daily orally and dissolved in water. Intervention Group 3: No training + wheat germ extract. Subjects will receive 2.5 grams of NBS Superfood supplement containing wheat germ extract orally and dissolved in water daily for 8 weeks. The supplement will be provided by NBS Superfood (NBS Organic Company, Turkey). Control group: No training + placebo. Subjects will receive 2.5 grams of placebo (potato starch) orally dissolved in water daily for 8 weeks. This group will not participate in any exercise program and will continue their usual lifestyle during the study period. Cortisol. Timepoint: Before the intervention and 8 weeks after the end of the intervention. Method of measurement: Saliva sample, ELISA kit, use of ELISA reader. C-reactive protein. Timepoint: Before the intervention and 8 weeks after the end of the intervention. Method of measurement: Saliva sample, ELISA kit, use of ELISA reader. Cognitive function (IVA-2 test). Timepoint: Before the intervention and 8 weeks after the end of the intervention. Method of measurement: Integrated Visual and Auditory Continuous Performance Test. Ayatollah Boroujerdi University Approved 2026-07-18 Research Ethics Committee of the Sports Sciences Research Institute Number 3,Fifth Alley -Mir Emad St.-Ostad Motahari St. Tehran Tehran Iran (Islamic Republic of)