Immunity
Conditions
Keywords
Porphyra Tenera
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.
Interventions
DIETARY_SUPPLEMENTEthanol Extracts of Porphyra Tenera(PTE10)
2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week
DIETARY_SUPPLEMENTPlacebo
Placebo for 8 week
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Natural Killer cell activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes of Cytokines | 0 week, 8 week | For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes. Inspection item were IL-2, IL-6, IL-12, IFN-γ, TNF-α. |
| Changes of Upper respiratory infection questionnaire score | 0 week, 4 week, 8 week | The upper respiratory infection questionnaire will investigate the occurrence of symptoms of upper respiratory infections (or symptoms), the score by symptom, the duration (days), and survey on the day of visit (1st, 2nd and 3rd visits). The questionnaire items were classified into three groups according to whether or not the symptoms of upper respiratory infections (or symptoms) occurrence (yes or no), the types of symptoms (sore throat, rhinorrhea, nasal obstruction, sneezing, hoarseness, myalgia, earache, fever, headache, cough, sputum, dyspnea, diarrhea, nausea, vomiting)and symptoms level (0 if no symptoms, 1 if slightly, 2 if normal, 3 severe). |
Countries
South Korea
Contacts
Primary ContactSoo Wan Chae, Ph.D., M.D.
Outcome results
None listed