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

September 18, 2018 updated by: Jong Ho Lee, Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Group- 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
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
Placebo Comparator: Control Group - Placebo Product
  • Ingredient: Corn starch
  • Type: HPMC capsule
  • Weight: 300mg/capsule
  • Directions: 2 capsules, twice a day
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WBC(White blood cell) Count
Time Frame: at 8 week
WBC(White blood cell) Count
at 8 week
NK(Natural killer) cell activity
Time Frame: at 8 week
NK(Natural killer) cell activity
at 8 week
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Time Frame: at 8 week
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
at 8 week
Evaluation of improvement by the subjects themselves
Time Frame: at 8 week
Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
at 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: at 8 week
Number of Participants with Adverse reactions
at 8 week
Body temperature
Time Frame: at 8 week
Body temperature
at 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: JONGHO LEE, Ph.D., Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2017

Primary Completion (Actual)

August 10, 2018

Study Completion (Actual)

September 10, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • YG_immune

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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