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

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03739970
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
3.4
Anticipated Duration (Months)
31.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Investigational Product (Silk Peptide)
  • Dietary Supplement: Control Group - Placebo Product
 N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 15, 2018
Anticipated Primary Completion Date :
Jan 29, 2019
Anticipated Study Completion Date :
Feb 28, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. IFN-γ [0 week, 8 week]

    Changes of IFN-γ were before and after the intervention

  2. TNF-α [0 week, 8 week]

    Changes of TNF-α were before and after the intervention

  3. IL-1β [0 week, 8 week]

    Changes of IL-1β were before and after the intervention

  4. IL-2 [0 week, 8 week]

    Changes of IL-2 were before and after the intervention

  5. IL-6 [0 week, 8 week]

    Changes of IL-6 were before and after the intervention

  6. IL-12 [0 week, 8 week]

    Changes of IL-12 were before and after the intervention

  7. IgG1 [0 week, 8 week]

    Changes of IgG1 were before and after the intervention

  8. IgG2 [0 week, 8 week]

    Changes of IgG2 were before and after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University. Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jong Ho Lee, Professor, Principal Investigator, Yonsei University
ClinicalTrials.gov Identifier:
NCT03739970
Other Study ID Numbers:
  • 201709-HR-763
First Posted:
Nov 14, 2018
Last Update Posted:
Nov 14, 2018
Last Verified:
Nov 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 14, 2018