A Clinical Trial of Silk Peptide for the Evaluation of Efficacy on Immune Function
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedNovember 14, 2018
November 1, 2018
3 months
October 31, 2018
November 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
NK(Natural killer) cell activity
Changes of NK(Natural killer) cell activity were before and after the intervention
0 week, 8 week
Secondary Outcomes (8)
IFN-γ
0 week, 8 week
TNF-α
0 week, 8 week
IL-1β
0 week, 8 week
IL-2
0 week, 8 week
IL-6
0 week, 8 week
- +3 more secondary outcomes
Study Arms (2)
Investigational Group- Silk Peptide
EXPERIMENTAL* 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
PLACEBO COMPARATOR* 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
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- Adult male and female volunteers over 50 years
- Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
- Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
You may not qualify if:
- Those with a history of drug and clinically significant hypersensitivity reactions
- Those with thyroid or pituitary disease
- Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke
- Those with immune system disease or severe liver failure, kidney failure or history
- Those with a history of systemic diseases such as malignancy, lung disease, leukemia, collagenosis, multiple sclerosis, allergic skin disease and other autoimmune diseases
- Those with a BMI of less than 18.5 kg/m2 at screening
- Those diagnosed with diabetes
- 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
- 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.)
- Those who have received antipsychotic medication within 2 months before screening
- Those with a alcoholism or history of substance abuse
- Those who participated in other clinical trials within 2 months before screening
- Those who are pregnant, breastfeeding
- Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)
- Those who are deemed inappropriate by the researcher
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 03722, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
JONGHO LEE, Ph.D.
Yonsei University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Principal Investigator
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 14, 2018
Study Start
November 15, 2018
Primary Completion
January 29, 2019
Study Completion
February 28, 2019
Last Updated
November 14, 2018
Record last verified: 2018-11