Clinical trial NCT04017988: Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) on Promotion of Immunity
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunity
Keywords: Porphyra Tenera
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Natural Killer cell activity
timeFrame: 0 week, 8 week
Secondary outcomes:
measure: Changes of Cytokines
timeFrame: 0 week, 8 week
measure: Changes of Upper respiratory infection questionnaire score
timeFrame: 0 week, 4 week, 8 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: