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

Study Overview

• Status: Unknown
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ethanol Extracts of Porphyra Tenera(PTE10)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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 Comparator: 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)	Dietary supplement: Placebo; Placebo for 8 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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-γ, TNF-α.	0 week, 8 week
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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Porphyra Tenera
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: JBF-PI-PTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No