The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue

Study Overview
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Brief Summary
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To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue

Official Title
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The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Polygonatum kingianum extract drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged 30-60 years old Must read and sign the informed consent form During the experiment, do not change the lifestyle and eating habits Cooperate not to engage in high-intensity exercise 48 hours before each experiment Exclusion Criteria: Subject who is not willing to participate in this study. People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients People who have undergone surgery within 6 months or have lower limb injuries People who are allergic to Polygonatum kingianum extract Participate in other clinical trials related to anti-fatigue within four weeks of the trial Students who are currently taking courses taught by the principal investigator of this trial.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo drink<br>consume 1 bottle per day | Dietary Supplement: Placebo drink<br>* consume 1 bottle per day<br>|
| Experimental: Polygonatum kingianum extract drink<br>consume 1 bottle per day | Dietary Supplement: Polygonatum kingianum extract drink<br>* consume 1 bottle per day<br>* Other names: Dragon Power® Polygonatum kingianum extract drink;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of aerobic endurance | 3-min step test is used to assess aerobic endurance | Day 0, day 14, day28 | 
| The change of continuous attention performance | Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance | Day 0, day 14, day28 | 
| The change of concentration of testosterone in blood | Fasting venous blood was sampled to measure concentrations of testosterone | Day 0, day 14, day28 | 
| The change of blood PDE5 gene expression | Fasting venous blood was sampled to measure the expression of PDE5 gene | Day 0, day 14, day28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of blood nitric oxide (NO) | Fasting venous blood was sampled to measure concentrations of nitric oxide | Day 0, day 14, day28 | 
| The change of self-assessment fatigue condition | A 10 point likert scale was utilized to evaluate fatigue condition. The higher the score, the higher the fatigue level. | Day 0, day 14, day28 |