A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function Enhancement

Conditions
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Normal Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Investigational Product (Silk Peptide)
* Dietary Supplement: Control Group - Placebo Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female volunteers over 50 years Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative Exclusion Criteria: Those with a history of drug and clinically significant hypersensitivity reactions Those with thyroid or pituitary disease Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke Those with immune system disease or severe liver failure, kidney failure or history Those with a history of systemic diseases such as malignancy, lung disease, leukemia, collagenosis, multiple sclerosis, allergic skin disease and other autoimmune diseases Those with a BMI of less than 18.5 kg/m2 at screening Those diagnosed with diabetes 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 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.) Those who have received antipsychotic medication within 2 months before screening Those with a alcoholism or history of substance abuse Those who participated in other clinical trials within 2 months before screening Those who are pregnant, breastfeeding Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation) Those who are deemed inappropriate by the researcher

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Group- Silk Peptide<br>Ingredient: Silk Peptide Type: Yellow granule stick Weight: Silk Peptide 9g/day Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day) Duration of use: 8 weeks | Dietary Supplement: Investigational Product (Silk Peptide)<br>* 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<br>|
| Placebo Comparator: Control Group - Placebo Product<br>Ingredient: Microcrystalline Cellulose Type: Yellow granule stick Weight: Silk Peptide 0g/day Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day) Duration of use: 8 weeks | Dietary Supplement: Control Group - Placebo Product<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK(Natural killer) cell activity | Changes of NK(Natural killer) cell activity were before and after the intervention | 0 week, 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IFN-γ | Changes of IFN-γ were before and after the intervention | 0 week, 8 week | 
| TNF-α | Changes of TNF-α were before and after the intervention | 0 week, 8 week | 
| IL-1β | Changes of IL-1β were before and after the intervention | 0 week, 8 week | 
| IL-2 | Changes of IL-2 were before and after the intervention | 0 week, 8 week | 
| IL-6 | Changes of IL-6 were before and after the intervention | 0 week, 8 week | 
| IL-12 | Changes of IL-12 were before and after the intervention | 0 week, 8 week | 
| IgG1 | Changes of IgG1 were before and after the intervention | 0 week, 8 week | 
| IgG2 | Changes of IgG2 were before and after the intervention | 0 week, 8 week |