NCT04017988

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

July 10, 2019

Last Update Submit

July 10, 2019

Conditions

Immunity

Keywords

Porphyra Tenera

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes of Cytokines

    0 week, 8 week

  • Changes of Upper respiratory infection questionnaire score

    0 week, 4 week, 8 week

Study Arms (2)

Ethanol Extracts of Porphyra Tenera(PTE10) group

EXPERIMENTAL

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)

Placebo group

PLACEBO COMPARATOR

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

Interventions

Ethanol Extracts of Porphyra Tenera(PTE10)DIETARY_SUPPLEMENT

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

Ethanol Extracts of Porphyra Tenera(PTE10) group
PlaceboDIETARY_SUPPLEMENT

Placebo for 8 week

Placebo group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

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

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

June 13, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

KR(1)