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CompletedNCT03677921NYGUpdated Sep 20, 2018

A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function

An interventional study of Investigational Product (Bio-Germanium) and Control Group - Placebo Product in Normal Healthy Subjects, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-20.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Dec 2017, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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 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).

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Conditions studied

  • Normal Healthy Subjects
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male and female volunteers between the ages of 25 to 75 years
  2. Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
  3. Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
  3. Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
  4. Those received vaccination within 3 months before screening
  5. Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
  6. Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
  7. Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
  8. Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
  9. Those who are pregnant, breastfeeding or planning to become pregnant during this study
  10. Those who are oversensitive or allergic to the investigational product
  11. Those who plan to participate in other researches during this study
  12. Those who participated in other researches within 4 weeks of the start of this study
  13. Those who are deemed inappropriate by the researcher
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Investigational Group- 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

    Dietary Supplement: Investigational Product (Bio-Germanium)

  • Placebo comparator
    Control Group - Placebo Product

    * Ingredient: Corn starch * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day * Duration of use: 8 weeks

    Dietary Supplement: Control Group - Placebo Product

Interventions

  • Dietary supplementInvestigational 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 supplementControl 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

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What researchers measure

Primary outcomes

  1. WBC(White blood cell) Count

    WBC(White blood cell) Count

    Time frame: at 8 week

  2. NK(Natural killer) cell activity

    NK(Natural killer) cell activity

    Time frame: at 8 week

  3. 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)

    Time frame: at 8 week

  4. Evaluation of improvement by the subjects themselves

    Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)

    Time frame: at 8 week

Secondary outcomes

  1. Adverse reactions

    Number of Participants with Adverse reactions

    Time frame: at 8 week

  2. Body temperature

    Body temperature

    Time frame: at 8 week

07

Study locations

1 site
  • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
    Seoul, 03722, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03677921
Lead sponsor
Yonsei University
Responsible party
Jong Ho Lee (Professor, Principal Investigator, Yonsei University) — Principal investigator
First posted
Sep 19, 2018
Start date
Dec 10, 2017
Primary completion
Aug 10, 2018
Completion
Sep 10, 2018
Last update
Sep 20, 2018

Study contacts

JONGHO LEE, Ph.D.
principal investigator · Yonsei University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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