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

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

Detailed Description
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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.

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

Conditions
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Fatigue Syndrome, Chronic, Cold

Intervention / Treatment
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* Dietary Supplement: Antrodia cinnamomea mycelia
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placeo group | Dietary Supplement: Placebo<br>* Placebo capsule, two capsules/day (600 mg/day) for 3 months<br>|
| Experimental: Treatment<br>Experimental group | Dietary Supplement: Antrodia cinnamomea mycelia<br>* Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune analysis | Changes in T cell markers of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Immune analysis | Changes in B cell markers of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Antibody analysis | Changes in IgA levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Antibody analysis | Changes in IgD levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Antibody analysis | Changes in IgG levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Antibody analysis | Changes in IgE levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Antibody analysis | Changes in IgM levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Cytokine analysis | Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Cytokine analysis | Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Cytokine analysis | Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Cytokine analysis | Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks | 
| Cytokine analysis | Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4. | Baseline up to 4 weeks |