A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) on Promotion of Immunity
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Changes of Natural Killer cell activity
Study Overview
Brief Summary
This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity
Detailed Description
This study was 8 weeks, randomized, double-blind, placebo-controlled human trial. 120 subjects were randomly divided into ethanol extracts of Porphyra tenera(PTE10) group or placebo group. The investigators measure Natural Killer cell activity, Cytokines(IL-2, IL-6, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females aged 50 years over at the screening
- •Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Exclusion Criteria
- •Patients whose white blood cell(WBC)<3000/㎕ or >8000/㎕ in the screening examination
- •Patients receiving influenza vaccination within 3 months before the screening examination
- •Patients who have a body mass index(BMI)<18.5 kg / m^2 or ≥35 kg / m^2 at the screening examination
- •Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
- •Patients who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination
- •Patients receiving antipsychotic medication within 3 months prior to the screening examination
- •Patients who alcoholic or drug abuse suspected
- •Patients who have participated in other clinical trials within 3 months prior to the screening examination
- •Patients who show the following relevant results in a Laboratory test
- •Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dl
- •Patients who are pregnant or breastfeeding
- •Patients who may become pregnant and have not used appropriate contraceptives
- •Patients who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Arms & Interventions
Ethanol Extracts of Porphyra Tenera(PTE10) group
2 times a day, 2 capsules for 1 time, after breakfast/dinner meal (2.512 g/day, Ethanol Extracts of Porphyra Tenera(PTE10) 2.5 g/day)
Intervention: Ethanol Extracts of Porphyra Tenera(PTE10) (Dietary Supplement)
Placebo group
2 times a day, 2 capsules for 1 time, after breakfast/dinner meal (2.512 g/day, Ethanol Extracts of Porphyra Tenera(PTE10) 0 g/day)
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes of Natural Killer cell activity
Time Frame: 0 week, 8 week
Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 50:1, 25:1, 12.5:1. (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
Secondary Outcomes
- Changes of Cytokines(0 week, 8 week)
- Changes of Upper respiratory infection questionnaire score(0 week, 4 week, 8 week)
Investigators
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital