None listed
Conditions
Interventions
Others(diet) : 1. Rice-based diet group: A 12-week rice-based breakfast is prepared by the research institution.
2. Wheat-based diet group: A 12-week wheat-based breakfast is prepared by the research
Sponsors
Chonbuk National University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Middle and high school students who are 12 to 18 years old at the time of screening test 2) A person classified as 'low weight group' below 15th percentile, 'normal weight group' 15th to 97th percentile, 'obesity group’ over 97th in body mass index (kg/m2) of childhood and adolescence growth charts at the time of screening 3) A person who agree to voluntarily decide to participate and to comply with the notice after fully hearing and understanding the details of this human body test
Exclusion criteria
Exclusion criteria: 1) A person who has drunken more than 1 bottle of soju or has smoked a pack of cigarrete before 4-week of screening 2) A person with a history of treatment with Axis I disorder or who has been treated within 3 years before screening in SCID (Structured Clinical Interview fot DSM-IV), which is a structured clinical interview of the Diagnosis and Statistical Manual of Mental Disorders conducted at the time of screening 3) A person who lost more than 10% of their weight within 3 months before the screening test 4) A person who has taken medicines or health functional foods related to adolescent health factors more than 5 times a week within one month before screening test (see prohibited medication) 5) A person with clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, hepatic, and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders that require treatment 6) A systolic blood pressure less than 90 mmHg or greater than 150 mmHg or a diastolic blood pressure less than 60 mmHg or greater than 95 mmHg 7) A person who has a history of hypersensitivity or clinically significant hypersensitivity to certain foods 8) A person who has taken any OTC medicine or herbal medicine within 2 weeks prior to the screening test or any OTC or dietary supplement, probiotics, laxatives, dietary fiber, or vitamin preparation within 1 week of screening test 9) A person who has participated in other human trial within three months of screening test 10) A person who has donated whole blood within one month or apheresis blood within 2 weeks before the screening test 11) A person who can’t perform the eating test 12) A person who shows the following in a diagnostic examination medical examination ? Serum AST, ALT > three times of the reference upper limit 13) A person who has determined that a tester is unsuitable for participating in human factors testing for reasons other than diagnostic testing medical examination result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric(Weight, body mass index, body fat mass, body fat percent, lean body mass, waist circumference, hip circumference, and waist-hip circumference ratio) | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory factors (hs-CRP, ESR);Lipid profile (Total cholesterol, Triglyceride, LDL-cholestrol, HDL- cholesterol) ;Glucose profile (fasting blood glucose, HbA1c, insulin, HOMA-IR) ;Brain wave, ECG (electrocardiogram);Brief Cognitive Rating Scale(BCRS);Stress arousal checklist(SACL);Bowel habit;Metabolome analysis;Liver function (AST, ALT, GGT, ALP, BUN);Vital sign (systolic/diastolic blood pressure, pulse) ;Cortisol (saliva);Atherosclerosis indices(LDL-C/HDL-C, TG/HDL-C, TC/HDL-C ratio);Diet intake survey | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Kim
Chonbuk National University Hospital
Outcome results
None listed