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

Normal Healthy Subjects Clinical Trial

— NYG  

Official title:

A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677921
• Other study ID #: YG_immune
• Status: Completed
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Normal Healthy Subjects

Intervention

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) Storage: Room temperature (below 25?) Duration of use: 8 weeks
• 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

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WBC(White blood cell) Count	WBC(White blood cell) Count	at 8 week
Primary	NK(Natural killer) cell activity	NK(Natural killer) cell activity	at 8 week
Primary	Immune related indicator (IFN-?, IL-2, 6, 12, TNF-a, IgG1, IgG2, IgM)	Immune related indicator (IFN-?, IL-2, 6, 12, TNF-a, IgG1, IgG2, IgM)	at 8 week
Primary	Evaluation of improvement by the subjects themselves	Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)	at 8 week
Secondary	Adverse reactions	Number of Participants with Adverse reactions	at 8 week
Secondary	Body temperature	Body temperature	at 8 week