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

NCT03677921 | Completed DMC

• 1 other identifier: YG_immune
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• WBC(White blood cell) Count

  WBC(White blood cell) Count

  at 8 week

• NK(Natural killer) cell activity

  NK(Natural killer) cell activity

  at 8 week

• Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)

  Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)

  at 8 week

• 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 Outcomes (2)

• Adverse reactions

  at 8 week

• Body temperature

  at 8 week

Study Arms (2)

Investigational Group- Bio-Germanium

EXPERIMENTAL

* 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)

Control Group - Placebo Product

PLACEBO COMPARATOR

* 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

Interventions

Investigational Product (Bio-Germanium) DIETARY_SUPPLEMENT

* 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

Investigational Group- Bio-Germanium

Control Group - Placebo Product DIETARY_SUPPLEMENT

* 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

Control Group - Placebo Product

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female volunteers between the ages of 25 to 75 years
• Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
• Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative

You may not qualify if:

• 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)
• Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
• Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
• Those received vaccination within 3 months before screening
• Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
• Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
• Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
• Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
• Those who are pregnant, breastfeeding or planning to become pregnant during this study
• Those who are oversensitive or allergic to the investigational product
• Those who plan to participate in other researches during this study
• Those who participated in other researches within 4 weeks of the start of this study
• Those who are deemed inappropriate by the researcher

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 03722, South Korea

Location

Related Publications (1)

• Cho JM, Chae J, Jeong SR, Moon MJ, Shin DY, Lee JH. Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights. PLoS One. 2020 Oct 19;15(10):e0240358. doi: 10.1371/journal.pone.0240358. eCollection 2020.

  PMID: 33075061 DERIVED

Study Officials

• JONGHO LEE, Ph.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 19, 2018
• Study Start: December 10, 2017
• Primary Completion: August 10, 2018
• Study Completion: September 10, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)