None listed
Conditions
Interventions
Dietary Supplement : The test group takes the test food (MEDI-Y-PEP), which is a caramel-type chew(1800mg), and the main ingredient of the test food is egg yolk peptide. One tablet is chewed twice a d
Sponsors
Medience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pediatric males and females aged 5 to 12 years at the time of the screening visit 2) Children before secondary sexual characteristics who fall within the 3rd percentile of the Korean age-specific height percentile growth curve for the same gender and age group and are diagnosed by a specialist. 3) Ability to understand and comply with the test methods and procedures in this human application protocol. 4) Voluntarily agree to participate in this human clinical trial and give written informed consent to the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1) Those who fall below the 3rd percentile or -2SD of the Korean age-specific height percentile growth curve for the same gender and age group 2) Children showing signs of secondary sexual characteristics. * Boys: Increased testicular volume (greater than 2.5 cm, greater than 4 ml), scrotal pigmentation, and long hairs at the base of the penis. Girls: slightly enlarged nipples and breasts, and long hairs around the labia. 3) If anemia is present * ~6 years: Hb<11 g/dL, 6-14 years: Hb<12 g/dL 4) Weight for age is below the 5th percentile according to WHO Growth Standards. *In the 2017 Korean Growth Chart for Children and Adolescents (Korea Centers for Disease Control and Prevention), weight below the 5th percentile for age is considered "underweight" and is classified as failure to thrive. 5) Endocrine disorders (growth hormone deficiency (<10 ng/mL), hypothyroidism, rickets, pituitary tumors, type 1 diabetes, etc.) 6) Subjects with chromosomal abnormalities (such as gonadal dysplasia), genetic abnormalities, or other syndromes. 7) Subjects who are being treated for or have a history of clinically significant liver, kidney, pancreas, nervous system, respiratory system, hematologic tumors, psychiatric disorders, cardiovascular system, urinary system, or infections. 8) Have any other medical condition that the investigator believes may interfere with the clinical evaluation. 9) Use of height growth-related medications, herbal medicines, and foods within 3 months of the screening visit. 10) History of or treatment with hormone replacement therapy, calcitonin, phosphonate, growth hormone, or growth hormone injections within 6 months prior to the screening visit. 11) Taking ADHD medication * Drugs such as methylphenidate may cause growth retardation as a side effect of the drug 12) Hypersensitivity to the main ingredients or components of the test food * Main ingredient: yolk (egg yolk) 13) Those who have participated or plan to participate in other clinical trials and human application trials within the last 3 months. 14) Subjects with abnormalities in blood or urine tests performed at the screening examination prior to the start of the human clinical trial. - Serum creatinine = 2.0mg/dL - AST, ALT = 2 times the upper limit of reference range 15) Any other person deemed inappropriate for participation in the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height | — |
Secondary
| Measure | Time frame |
|---|---|
| Growth Rate ;Standardized score for height by age ;Bone Age and Growth Plates;Growth-related markers (GH, IGF-1, IGFBP-3) | — |
Countries
Korea, Republic of
Contacts
Public ContactJihong Lee
Daegu Haany University
Outcome results
None listed