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

Not Applicable

• Conditions: Immunity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ethanol Extracts of Porphyra Tenera(PTE10)

• Registration Number: NCT04017988
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2019-06-13
• Status Verified: 2019-07
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	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)
Ethanol Extracts of Porphyra Tenera(PTE10) group	Ethanol Extracts of Porphyra Tenera(PTE10)	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)

Primary Outcome Measures

Name	Time	Method
Changes of Natural Killer cell activity	0 week, 8 week	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

Secondary Outcome Measures

Name	Time	Method
Changes of Cytokines	0 week, 8 week	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.
Changes of Upper respiratory infection questionnaire score	0 week, 4 week, 8 week	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).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of