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

Not Applicable

Completed

• Conditions: Normal Healthy Subjects
• Interventions: Dietary Supplement: Investigational Product (Bio-Germanium); Dietary Supplement: Control Group - Placebo Product

• Registration Number: NCT03677921
• Lead Sponsor: Yonsei University

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).

Study Timeline

• Study Start: 2017-12-10
• Primary Completion: 2018-08-10
• Status Verified: 2018-09
• Study Completion: 2018-09-10
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-17
• Last Update Submitted: 2018-09-18
• Study First Posted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Group- Bio-Germanium	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	Control Group - Placebo Product	* Ingredient: Corn starch * Type: HPMC capsule * Weight: 300mg/capsule * Directions: 2 capsules, twice a day * Duration of use: 8 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body temperature	at 8 week	Body temperature
Adverse reactions	at 8 week	Number of Participants with Adverse reactions

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of