NCT03739970UnknownNot Applicable
A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function Enhancement
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- NK(Natural killer) cell activity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Investigational Group- Silk Peptide
Experimental
- 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
Intervention: Investigational Product (Silk Peptide) (Dietary Supplement)
Control Group - Placebo Product
Placebo Comparator
- 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
Intervention: Control Group - Placebo Product (Dietary Supplement)
Outcomes
Primary Outcomes
NK(Natural killer) cell activity
Time Frame: 0 week, 8 week
Changes of NK(Natural killer) cell activity were before and after the intervention
Secondary Outcomes
- IgG2(0 week, 8 week)
- TNF-α(0 week, 8 week)
- IgG1(0 week, 8 week)
- IFN-γ(0 week, 8 week)
- IL-1β(0 week, 8 week)
- IL-2(0 week, 8 week)
- IL-6(0 week, 8 week)
- IL-12(0 week, 8 week)
Investigators
Jong Ho Lee
Professor, Principal Investigator
Yonsei University
Study Sites (1)
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