ImmunityNCT04017988
Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) on Promotion of Immunity
A study testing Ethanol Extracts of Porphyra Tenera(PTE10) in people with Immunity, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunity
- What is being tested?
- Ethanol Extracts of Porphyra Tenera(PTE10)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Soo-Wan Chae, MD., PhD, 82-63-259-3040, swchae@jbctc.org
About this study
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
This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity
Read the 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.
- Conditions
- Immunity
- Being tested
- Ethanol Extracts of Porphyra Tenera(PTE10), Placebo
- Keywords
- Porphyra Tenera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol Extracts of Porphyra Tenera(PTE10)Dietary supplement
2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week
PlaceboDietary supplement
Placebo for 8 week
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 week, 8 week
Secondary outcomes (2)
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.
Measured: 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).
Measured: 0 week, 4 week, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start13 Jun 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017988
- Sponsor's protocol ID
- JBF-PI-PTE
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04017988
- Acronym / sponsor ID
- JBF-PI-PTE
- Conditions
- Immunity
- Keywords
- Porphyra Tenera
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol Extracts of Porphyra Tenera(PTE10) group | Experimental | Dietary Supplement: 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) |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo2 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol Extracts of Porphyra Tenera(PTE10)2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week | Dietary supplement | Ethanol Extracts of Porphyra Tenera(PTE10) group |
| PlaceboPlacebo for 8 week | Dietary supplement | Placebo group |
Primary outcome
Changes of Natural Killer cell activity
Time frame: 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
2 secondary outcomes
Changes of Cytokines
Time frame: 0 week, 8 week
Changes of Upper respiratory infection questionnaire score
Time frame: 0 week, 4 week, 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol Extracts of Porphyra Tenera(PTE10) in people with Immunity, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Wan Chae, Ph.D., M.D. (82-63-259-3040, soowan@jbnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Natural Killer cell activity (time frame: 0 week, 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.