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

Not Applicable

• Conditions: Normal Healthy Subjects
• Interventions: Dietary Supplement: Investigational Product (Silk Peptide); Dietary Supplement: Control Group - Placebo Product

• Registration Number: NCT03739970
• Lead Sponsor: Yonsei University

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 Timeline

• Study First Submitted: 2018-10-31
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Study Start: 2018-11-15
• Primary Completion: 2019-01-29
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Group- Silk Peptide	Investigational Product (Silk Peptide)	* 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
Control Group - Placebo Product	Control Group - Placebo Product	* 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

Primary Outcome Measures

Name	Time	Method
NK(Natural killer) cell activity	0 week, 8 week	Changes of NK(Natural killer) cell activity were before and after the intervention

Secondary Outcome Measures

Name	Time	Method
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-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
IL-12	0 week, 8 week	Changes of IL-12 were before and after the intervention

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of