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

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

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.

Study Overview

• Status: Unknown
• Conditions: Normal Healthy Subjects
• Intervention / Treatment: Dietary supplement: Investigational Product (Silk Peptide); Dietary supplement: Control Group - Placebo Product

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
    • Contact: Jong Lee, Ph.D.; Phone Number: +82-2-2123-3122; Email: jhleeb@yonsei.ac.kr
    • Principal Investigator: Jong Ho Lee, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Group- 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	Dietary supplement: Investigational 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
Placebo Comparator: 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	Dietary supplement: Control 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: JONGHO LEE, Ph.D., Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2018
• Primary Completion (Anticipated): January 29, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201709-HR-763

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No