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
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes of Natural Killer cell activity
研究概览
简要总结
This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: 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)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes of Natural Killer cell activity
时间窗: 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
次要结局
- Changes of Cytokines(0 week, 8 week)
- Changes of Upper respiratory infection questionnaire score(0 week, 4 week, 8 week)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital