Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) on Promotion of Immunity

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

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.

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