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Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People

Sponsor
Greenyn Biotechnology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728918
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Antrodia cinnamomea mycelia
  • Dietary Supplement: Placebo
 N/A

Detailed Description

This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placeo group

Dietary Supplement: Placebo
Placebo capsule, two capsules/day (600 mg/day) for 3 months
Experimental: Treatment

Experimental group

Dietary Supplement: Antrodia cinnamomea mycelia
Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months

Outcome Measures

Primary Outcome Measures

  1. Immune analysis [Baseline up to 4 weeks]

    Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.

  2. Immune analysis [Baseline up to 4 weeks]

    Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.

  3. Antibody analysis [Baseline up to 4 weeks]

    Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.

  4. Antibody analysis [Baseline up to 4 weeks]

    Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.

  5. Antibody analysis [Baseline up to 4 weeks]

    Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.

  6. Antibody analysis [Baseline up to 4 weeks]

    Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.

  7. Antibody analysis [Baseline up to 4 weeks]

    Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.

  8. Cytokine analysis [Baseline up to 4 weeks]

    Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.

  9. Cytokine analysis [Baseline up to 4 weeks]

    Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.

  10. Cytokine analysis [Baseline up to 4 weeks]

    Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.

  11. Cytokine analysis [Baseline up to 4 weeks]

    Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.

  12. Cytokine analysis [Baseline up to 4 weeks]

    Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Subjects are easy to feel fatigued

  • Subjects have poor sleep quality

Exclusion Criteria:

  • Pregnant women or preparing for pregnancy.

  • Lactating women.

  • Women gave birth 6 months before the study.

  • Poor kindy and livers funcitons

  • Severe cardiovascular or other chronic diseases

  • Alcohol abuser

  • Using immune-associated supplements

Contacts and Locations

Locations

Site City State Country Postal Code
1 WanFang Hospital Taipei Taiwan 116

Sponsors and Collaborators

  • Greenyn Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Ming-Shun Wu, MD, WanFang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Greenyn Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05728918
Other Study ID Numbers:
  • A-111-091
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatigue Syndrome, Chronic

Study Results

No Results Posted as of Feb 15, 2023