Normal Healthy SubjectsNYGNCT03677921
A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function
A study testing Investigational Product (Bio-Germanium) in people with Normal Healthy Subjects, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Subjects
- What is being tested?
- Investigational Product (Bio-Germanium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2017to 10 Sep 2018
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers between the ages of 25 to 75 years
- Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
- Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
Who cannot join
- Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher)
- Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
- Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
- Those received vaccination within 3 months before screening
- Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
- Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
Show all 13Show fewer
- Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
- Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
- Those who are pregnant, breastfeeding or planning to become pregnant during this study
- Those who are oversensitive or allergic to the investigational product
- Those who plan to participate in other researches during this study
- Those who participated in other researches within 4 weeks of the start of this study
- Those who are deemed inappropriate by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 03722
About this study
Official title: A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.
Read the detailed description
This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).
- Conditions
- Normal Healthy Subjects
- Being tested
- Investigational Product (Bio-Germanium), Control Group - Placebo Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product (Bio-Germanium)Dietary supplement
- Ingredient: Bio-Germanium
- Type: HPMC capsule
- Weight: 300mg/capsule
- Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
- Storage: Room temperature (below 25℃)
- Duration of use: 8 weeks
Control Group - Placebo ProductDietary supplement
- Ingredient: Corn starch
- Type: HPMC capsule
- Weight: 300mg/capsule
- Directions: 2 capsules, twice a day
- Storage: Room temperature (below 25℃)
- Duration of use: 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group- Bio-Germanium | Experimental | * Ingredient: Bio-Germanium
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
* Duration of use: 8 weeks Receives: Dietary Supplement: Investigational Product (Bio-Germanium) |
| Control Group - Placebo Product | Placebo comparator | * Ingredient: Corn starch
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day
* Duration of use: 8 weeks Receives: Dietary Supplement: Control Group - Placebo Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
WBC(White blood cell) Count
WBC(White blood cell) Count
Measured: at 8 week
NK(Natural killer) cell activity
NK(Natural killer) cell activity
Measured: at 8 week
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Measured: at 8 week
Evaluation of improvement by the subjects themselves
Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
Measured: at 8 week
Secondary outcomes (2)
Adverse reactions
Number of Participants with Adverse reactions
Measured: at 8 week
Body temperature
Body temperature
Measured: at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start10 Dec 2017
- Primary completion10 Aug 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- JONGHO LEE, Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677921
- Sponsor's protocol ID
- YG_immune
- Acronym
- NYG
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho JM, Chae J, Jeong SR, Moon MJ, Shin DY, Lee JH. Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights. PLoS One. 2020 Oct 19;15(10):e0240358. doi: 10.1371/journal.pone.0240358. eCollection 2020.
PubMed 33075061
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation
- ClinicalTrials.gov ID
- NCT03677921
- Acronym / sponsor ID
- NYG / YG_immune
- Conditions
- Normal Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 19 Sep 2018 (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 is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.
Detailed description
This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Group- Bio-Germanium | Experimental | Dietary Supplement: Investigational Product (Bio-Germanium)* Ingredient: Bio-Germanium * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium) * Duration of use: 8 weeks |
| Control Group - Placebo Product | Placebo comparator | Dietary Supplement: Control Group - Placebo Product* Ingredient: Corn starch * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day * Duration of use: 8 weeks |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers between the ages of 25 to 75 years
- Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
- Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
Key exclusion criteria (13 listed)
- Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher)
- Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
- Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
- Those received vaccination within 3 months before screening
- Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
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 |
|---|---|---|
| Investigational Product (Bio-Germanium)* Ingredient: Bio-Germanium * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium) * Storage: Room temperature (below 25℃) * Duration of use: 8 weeks | Dietary supplement | Investigational Group- Bio-Germanium |
| Control Group - Placebo Product* Ingredient: Corn starch * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day * Storage: Room temperature (below 25℃) * Duration of use: 8 weeks | Dietary supplement | Control Group - Placebo Product |
Primary outcome
WBC(White blood cell) Count
Time frame: at 8 week
WBC(White blood cell) Count
NK(Natural killer) cell activity
Time frame: at 8 week
NK(Natural killer) cell activity
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Time frame: at 8 week
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Evaluation of improvement by the subjects themselves
Time frame: at 8 week
Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
2 secondary outcomes
Adverse reactions
Time frame: at 8 week
Body temperature
Time frame: at 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 33075061Cho JM, Chae J, Jeong SR, Moon MJ, Shin DY, Lee JH. Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights. PLoS One. 2020 Oct 19;15(10):e0240358. doi: 10.1371/journal.pone.0240358. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
JONGHO LEE, Ph.D. principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Product (Bio-Germanium) in people with Normal Healthy Subjects, run by Yonsei University 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 20 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WBC(White blood cell) Count (time frame: at 8 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677921, which also lists 1 linked publication.
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 20 Sep 2018.