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

Chonbuk National University

Status: Unknown

Conditions: Immunity

Treatments: Dietary Supplement: Ethanol Extracts of Porphyra Tenera(PTE10); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04017988

JBF-PI-PTE

Details and patient eligibility

About

This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Ethanol Extracts of Porphyra Tenera(PTE10) group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Ethanol Extracts of Porphyra Tenera(PTE10)

Placebo group

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo