Fatigue
Conditions
Brief summary
To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue
Interventions
DIETARY_SUPPLEMENTPlacebo drink
consume 1 bottle per day
DIETARY_SUPPLEMENTPolygonatum kingianum extract drink
consume 1 bottle per day
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of continuous attention performance | Day 0, day 14, day28 | Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance |
| The change of aerobic endurance | Day 0, day 14, day28 | 3-min step test is used to assess aerobic endurance |
| The change of concentration of testosterone in blood | Day 0, day 14, day28 | Fasting venous blood was sampled to measure concentrations of testosterone |
| The change of blood PDE5 gene expression | Day 0, day 14, day28 | Fasting venous blood was sampled to measure the expression of PDE5 gene |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of self-assessment fatigue condition | Day 0, day 14, day28 | A 10 point likert scale was utilized to evaluate fatigue condition. The higher the score, the higher the fatigue level. |
| The change of blood nitric oxide (NO) | Day 0, day 14, day28 | Fasting venous blood was sampled to measure concentrations of nitric oxide |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of concentrations of liver function biomarkers (AST, ALT) in blood | Day 0, day 14, day28 | Fasting venous blood was sampled to measure the concentration of liver function biomarkers- Aspartate amino transferase (AST), Alanine amino transferase (ALT). |
| The change of concentrations of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride) | Day 0, day 14, day28 | Fasting venous blood was sampled to measure lipid profiles- total cholesterol, Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C), triglyceride. |
| The change of concentrations of renal function biomarkers (BUN, creatinine) in blood | Day 0, day 14, day28 | Fasting venous blood was sampled to measure the concentration of renal function biomarkers- Blood Urea Nitrogen (BUN), creatinine. |
Countries
Taiwan
Outcome results
None listed