Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol Extracts of Porphyra Tenera(PTE10) group | Experimental | 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) |
|
| Placebo group | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol Extracts of Porphyra Tenera(PTE10) | Dietary Supplement | 2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Natural Killer cell activity | 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 | 0 week, 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Cytokines | 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. | 0 week, 8 week |
| Changes of Upper respiratory infection questionnaire score |
Not provided
Inclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo for 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). |
| 0 week, 4 week, 8 week |