NCT03677921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Normal Healthy Subjects

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2017-12-10
• Primary completion: 2018-08-10
• Completion: 2018-09-10
• First posted: 2018-09-19
• Last updated: 2018-09-20

Locations

1 site across 1 country: South Korea