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

NCT ID: NCT04017988

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Ethanol Extracts of Porphyra Tenera(PTE10)

Intervention Type DIETARY_SUPPLEMENT

2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 8 week

Interventions

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Ethanol Extracts of Porphyra Tenera(PTE10)

2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 8 week

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Wan Chae, Ph.D., M.D.

Role: CONTACT

82-63-259-3040

Facility Contacts

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Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

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JBF-PI-PTE

Identifier Type: -

Identifier Source: org_study_id

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