None listed
Conditions
Interventions
Others : A 8 week, randomized, doubleblind, placebocontrolled clinical trial of Enzymatic Hydrolysate of Skipjack Tuna Cooking Drip for the evaluation of efficacy and safety on immune function
Sponsors
Yonsei University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged from 25 to 75 years old. 2) Screening white blood cell(WBC) ranged from 4X103 to 10X103cells/ul. 3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense) 4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) 5) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Subjects who are currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic. (However, subjects are possible to participate in the study by the discretion of the study director) 2) Subjects who have uncontrolled high blood pressure. (Higher than 160/100mmHg, measured 10 minutes after stabilizing) 3) Patients with uncontrolled diabetes. (180mg/dl or higher fasting glucose, or beginning of a new drug within 3months due to diabetes) 4) Subjects who got a vaccination within 3months before screening. 5) Subjects whose AST (GOT) or ALT (GPT) exceeds 120IU/L in the blood. 6) Male whose creatinine exceeds 1.0mg/dL in the blood and female whose creatinine exceeds 1.8mg/dL in the blood. 7) Subjects who have intaken or is intaking functional foods that have potential of affecting the immune system. 8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion. 9) Subjects who are planning a pregnancy, breastfeeding during this study. 10) Subjects who are sensitive to foods or have food allergies. 11) Subjects who are planning to participate other studies during this study. 12) Subjects who were involved in other human applied studies within 4weeks of this study begins. 13) Subjects who are deemed to be inappropriate to this human applied study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse drug reactions ;White Bloold Cell count | — |
Secondary
| Measure | Time frame |
|---|---|
| vital sign(blood pressure, heart rate, body temperature), weight;clinical pathology examination ;NK cell activity(Natural killer cell Activity);IFN?(Interferon ?);IL6(Interleukin6), IL12(Interleukin12);TNFa(Tumor necrosis factor a);IgG1(Immunoglobulin G1), IgG2(Immunoglobulin G2);participant's self-evaluation regarding their health improvement | — |
Countries
Korea, Republic of
Contacts
Public ContactJongho Lee
Yonsei University
Outcome results
None listed