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

Yonsei University

Status: Unknown

Conditions: Normal Healthy Subjects

Treatments: Dietary Supplement: Investigational Product (Silk Peptide); Dietary Supplement: Control Group - Placebo Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03739970

201709-HR-763

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Investigational Group- Silk Peptide

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Investigational Product (Silk Peptide)

Control Group - Placebo Product

Placebo Comparator group

Description:

* 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

Treatment:

Dietary Supplement: Control Group - Placebo Product