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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739970
Recruitment Status : Unknown
Verified November 2018 by Jong Ho Lee, Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jong Ho Lee, Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Normal Healthy Subjects Dietary Supplement: Investigational Product (Silk Peptide) Dietary Supplement: Control Group - Placebo Product Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function Enhancement
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : January 29, 2019
Estimated Study Completion Date : February 28, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. IFN-γ [ Time Frame: 0 week, 8 week ]
    Changes of IFN-γ were before and after the intervention

  2. TNF-α [ Time Frame: 0 week, 8 week ]
    Changes of TNF-α were before and after the intervention

  3. IL-1β [ Time Frame: 0 week, 8 week ]
    Changes of IL-1β were before and after the intervention

  4. IL-2 [ Time Frame: 0 week, 8 week ]
    Changes of IL-2 were before and after the intervention

  5. IL-6 [ Time Frame: 0 week, 8 week ]
    Changes of IL-6 were before and after the intervention

  6. IL-12 [ Time Frame: 0 week, 8 week ]
    Changes of IL-12 were before and after the intervention

  7. IgG1 [ Time Frame: 0 week, 8 week ]
    Changes of IgG1 were before and after the intervention

  8. IgG2 [ Time Frame: 0 week, 8 week ]
    Changes of IgG2 were before and after the intervention


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739970


Contacts
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Contact: JONGHO LEE, Ph.D. 82-2-2123-3122 jhleeb@yonsei.ac.kr
Contact: JUNGMIN CHO, M.S. 82-2-2123-3122 jm092477@naver.com

Locations
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Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University. Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jong Lee, Ph.D.    +82-2-2123-3122    jhleeb@yonsei.ac.kr   
Principal Investigator: Jong Ho Lee, Ph.D.         
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: JONGHO LEE, Ph.D. Yonsei University
More Information
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Responsible Party: Jong Ho Lee, Professor, Principal Investigator, Yonsei University
ClinicalTrials.gov Identifier: NCT03739970    
Other Study ID Numbers: 201709-HR-763
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No