A 8 week, randomized, double-blind, placebo-controlled clinical trial of silk peptide for the evaluation of efficacy and safety on immune function enhancement
- Conditions
- Not Applicable
- Registration Number
- KCT0006122
- Lead Sponsor
- Yonsei University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
1) Healthy male and female volunteers over 50 years old
2) Screening result for WBC counts in between 3×103 cells/?~8×103 cells/?
3) Volunteers who have received specific experimental illustration and agreed to participate in the study and provided a written content by him/herself
1) Those received influenza vaccination within 3 months before screening
2) Those with BMI under 18.5 kg/m2 or over 30 kg/m2
3) Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as infectious, hematologic and neoplastic diseases
4) Those who have consumed medicine or health supplements that can affect immune function within 1 month before screening (See prohibited substances)
5) Those who have been treated with antipsychotics within 3 months before screening
6) Those with or suspected to have alcoholism or substance abuse
7) Those who participated in other researches within 3 months before screening
8) Those with these results in diagnostic medical examination
? blood AST or ALT levels greater than 3 times of upper limit from reference, serum creatinine level greater than 2.0 mg/dl
9) Those who are pregnant or breastfeeding during this study
10) Those who did not accept implementation of the appropriate contraception method among urban elligible women
11) Those who are deemed inappropriate by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunoglobulin (IgG1, IgG2);Upper airway infection survey score (occurrence status, symptom score, duration);NK(Natural Killer) cell activity;Immune related indicator (IFN-?, TNF-a, IL-6, IL-1ß, IL-2, IL-12, Adiponectin)
- Secondary Outcome Measures
Name Time Method Diagnostic medicine inspection (Hematological test, hemochemical test, urine test, pregnancy response test );Vital signs (blood pressure, pulse, body temperature);Survey on meal intake and activity;Adverse reactions;Physical examination/measurement