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A 8 week, randomized, double-blind, placebo-controlled clinical trial of silk peptide for the evaluation of efficacy and safety on immune function enhancement

A 8 week, randomized, double-blind, placebo-controlled clinical trial of silk peptide for the evaluation of efficacy and safety on immune function enhancement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006122
Enrollment
130
Registered
2021-05-06
Start date
2019-07-11
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Experimental Group - Investigational Product (Silk peptide) • Ingredient: Silk peptide (Sil-Q1) • Type: granular stick • Weight: 3.39g/stick • Directions: 1 stick, twice a day wit

Sponsors

Yonsei University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSeungmin Lee

Yonsei University

leeseungmin@yonsei.ac.kr+82-2-2123-3091

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026