Clincosm LogoSign in Get a demo

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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT03677921
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Investigational Product (Bio-Germanium)
  • Dietary Supplement: Control Group - Placebo Product
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation
Actual Study Start Date :
Dec 10, 2017
Actual Primary Completion Date :
Aug 10, 2018
Actual Study Completion Date :
Sep 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. WBC(White blood cell) Count [at 8 week]

    WBC(White blood cell) Count

  2. NK(Natural killer) cell activity [at 8 week]

    NK(Natural killer) cell activity

  3. 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)

  4. 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

  1. Adverse reactions [at 8 week]

    Number of Participants with Adverse reactions

  2. Body temperature [at 8 week]

    Body temperature

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University. Seoul Korea, Republic of 03722

Sponsors and Collaborators

  • Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jong Ho Lee, Professor, Principal Investigator, Yonsei University
ClinicalTrials.gov Identifier:
NCT03677921
Other Study ID Numbers:
  • YG_immune
First Posted:
Sep 19, 2018
Last Update Posted:
Sep 20, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 20, 2018