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Completed

NCT Number: NCT05728918

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

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

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Key information

Conditions

Fatigue Syndrome, Chronic Chronic Disease Cold Common Cold Disease Attributes Encephalomyelitis Infections Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WanFang Hospital

Taipei, 116, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antrodia cinnamomea mycelia

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo capsule, two capsules/day (600 mg/day) for 3 months

Primary outcomes

  1. Immune analysis

    Time frame: Baseline up to 4 weeks

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

  2. Immune analysis

    Time frame: Baseline up to 4 weeks

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

  3. Antibody analysis

    Time frame: Baseline up to 4 weeks

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

  4. Antibody analysis

    Time frame: Baseline up to 4 weeks

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

  5. Antibody analysis

    Time frame: Baseline up to 4 weeks

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

  6. Antibody analysis

    Time frame: Baseline up to 4 weeks

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

  7. Antibody analysis

    Time frame: Baseline up to 4 weeks

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

  8. Cytokine analysis

    Time frame: Baseline up to 4 weeks

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

  9. Cytokine analysis

    Time frame: Baseline up to 4 weeks

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

  10. Cytokine analysis

    Time frame: Baseline up to 4 weeks

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

  11. Cytokine analysis

    Time frame: Baseline up to 4 weeks

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

  12. Cytokine analysis

    Time frame: Baseline up to 4 weeks

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

Sponsors and collaborators

Lead sponsor

Greenyn Biotechnology Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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