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

Immunity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017988
• Other study ID #: JBF-PI-PTE
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2019
• Source: Chonbuk National University Hospital
• Contact: Soo Wan Chae, Ph.D., M.D.
• Phone: 82-63-259-3040
• Email: soowan[@]jbnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• Ethanol Extracts of Porphyra Tenera(PTE10)
2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week
• Placebo
Placebo for 8 week

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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-?, TNF-a.	0 week, 8 week
Secondary	Changes of Upper respiratory infection questionnaire score	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