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

Yonsei University

Status: Completed

Conditions: Normal Healthy Subjects

Treatments: Dietary Supplement: Investigational Product (Bio-Germanium); Dietary Supplement: Control Group - Placebo Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03677921

YG_immune

Details and patient eligibility

About

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.

Full 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).

Enrollment: 130 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

Investigational Group- Bio-Germanium

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Investigational Product (Bio-Germanium)

Control Group - Placebo Product

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control Group - Placebo Product