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

Normal Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739970
• Other study ID #: 201709-HR-763
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: November 2018
• Source: Yonsei University
• Contact: JONGHO LEE, Ph.D.
• Phone: 82-2-2123-3122
• Email: jhleeb[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 28, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Healthy Subjects

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NK(Natural killer) cell activity	Changes of NK(Natural killer) cell activity were before and after the intervention	0 week, 8 week
Secondary	IFN-?	Changes of IFN-? were before and after the intervention	0 week, 8 week
Secondary	TNF-a	Changes of TNF-a were before and after the intervention	0 week, 8 week
Secondary	IL-1ß	Changes of IL-1ß were before and after the intervention	0 week, 8 week
Secondary	IL-2	Changes of IL-2 were before and after the intervention	0 week, 8 week
Secondary	IL-6	Changes of IL-6 were before and after the intervention	0 week, 8 week
Secondary	IL-12	Changes of IL-12 were before and after the intervention	0 week, 8 week
Secondary	IgG1	Changes of IgG1 were before and after the intervention	0 week, 8 week
Secondary	IgG2	Changes of IgG2 were before and after the intervention	0 week, 8 week