Normal Healthy Subjects
Conditions
Brief summary
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Silk Peptide for the evaluation of efficacy on immune function enhancement.
Detailed description
This study will evaluate Silk Peptide's efficacy on immune function in healthy volunteers who white blood cells count is in between 4000/㎕ and 8000/㎕ by assessing improvements in certain immune indices (i.e. NK cell activity, IFN-γ, TNF-α, IL-1β, 2, 12, IgG1, IgG2).
Interventions
DIETARY_SUPPLEMENTInvestigational Product (Silk Peptide)
* Ingredient: Silk Peptide * Type: Yellow granule stick * Storage: Room temperature * Weight: Silk Peptide 9g/day * Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day) * Duration of use: 8 weeks
DIETARY_SUPPLEMENTControl Group - Placebo Product
* Ingredient: Microcrystalline Cellulose * Type: Yellow granule stick * Storage: Room temperature * Weight: Silk Peptide 0g/day * Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day) * Duration of use: 8 weeks
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult male and female volunteers over 50 years 2. Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul 3. Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
Exclusion criteria
1. Those with a history of drug and clinically significant hypersensitivity reactions 2. Those with thyroid or pituitary disease 3. Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke 4. Those with immune system disease or severe liver failure, kidney failure or history 5. Those with a history of systemic diseases such as malignancy, lung disease, leukemia, collagenosis, multiple sclerosis, allergic skin disease and other autoimmune diseases 6. Those with a BMI of less than 18.5 kg/m2 at screening 7. Those diagnosed with diabetes 8. Those with a history of gastrointestinal disorders (ex. Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial products 9. Those who have consumed medicines, healthy functional foods within 2 weeks before screening or are currently consuming health supplements that can affect immune function. (For health functional foods, they can participate through 1 week before the first intake day.) 10. Those who have received antipsychotic medication within 2 months before screening 11. Those with a alcoholism or history of substance abuse 12. Those who participated in other clinical trials within 2 months before screening 13. Those who are pregnant, breastfeeding 14. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation) 15. Those who are deemed inappropriate by the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NK(Natural killer) cell activity | 0 week, 8 week | Changes of NK(Natural killer) cell activity were before and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-1β | 0 week, 8 week | Changes of IL-1β were before and after the intervention |
| IL-2 | 0 week, 8 week | Changes of IL-2 were before and after the intervention |
| IL-6 | 0 week, 8 week | Changes of IL-6 were before and after the intervention |
| TNF-α | 0 week, 8 week | Changes of TNF-α were before and after the intervention |
| IgG1 | 0 week, 8 week | Changes of IgG1 were before and after the intervention |
| IgG2 | 0 week, 8 week | Changes of IgG2 were before and after the intervention |
| IFN-γ | 0 week, 8 week | Changes of IFN-γ were before and after the intervention |
| IL-12 | 0 week, 8 week | Changes of IL-12 were before and after the intervention |
Countries
South Korea
Contacts
Primary ContactJONGHO LEE, Ph.D.
Backup ContactJUNGMIN CHO, M.S.
Outcome results
None listed