Normal Healthy Subjects
Conditions
Brief 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.
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).
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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WBC(White blood cell) Count | at 8 week | WBC(White blood cell) Count |
| NK(Natural killer) cell activity | at 8 week | NK(Natural killer) cell activity |
| Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM) | at 8 week | Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM) |
| Evaluation of improvement by the subjects themselves | at 8 week | Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | at 8 week | Number of Participants with Adverse reactions |
| Body temperature | at 8 week | Body temperature |
Countries
South Korea
Outcome results
None listed