Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059036) titled 'Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study' on Sept. 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Individuals who habitually skip breakfast Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of breakfast and a mid-morning snack (supplemental meal) on concentration. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Skipping breakfast as usual Interventions/Control_2 - Ingest the prescribed breakfast by 8:00 AM.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - #1.Individuals aged 18 to 24 years old at the time of informed consent. #2.Individuals who can provide written informed consent for participation in this study. #3.Individuals who habitually skip breakfast on three or more weekdays out of five. #4.Individuals who typically wake up by around 8:00 AM. #5.Individuals who perceive difficulty in maintaining concentration during the morning and do not have a habit of taking naps. #6.Non-smokers (Individuals who do not have a smoking habit). Key exclusion criteria - #1.Individuals currently undergoing treatment for sleep disorders such as insomnia, or those self-administering over-the-counter sleep aids. #2.Individuals with a past or present diagnosis of an eating disorder. #3.Individuals currently undergoing treatment for mental illnesses such as depression. #4.Women who are pregnant, potentially pregnant, breastfeeding, or desiring pregnancy. #5.Individuals with food allergies. #6.Any other individuals deemed inappropriate by the principal investigator or co-investigators. Target Size - 66

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067527

Disclaimer: Curated by HT Syndication.