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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05877677
• Other study ID #: 23-027-A
• Status: Completed
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2023
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle per day
• Polygonatum kingianum extract drink
consume 1 bottle per day

Locations

Country	Name	City	State
Taiwan	National Pingtung University of Science and Technology	Pingtung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of concentrations of liver function biomarkers (AST, ALT) in blood	Fasting venous blood was sampled to measure the concentration of liver function biomarkers- Aspartate amino transferase (AST), Alanine amino transferase (ALT).	Day 0, day 14, day28
Other	The change of concentrations of renal function biomarkers (BUN, creatinine) in blood	Fasting venous blood was sampled to measure the concentration of renal function biomarkers- Blood Urea Nitrogen (BUN), creatinine.	Day 0, day 14, day28
Other	The change of concentrations of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride)	Fasting venous blood was sampled to measure lipid profiles- total cholesterol, Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C), triglyceride.	Day 0, day 14, day28
Primary	The change of aerobic endurance	3-min step test is used to assess aerobic endurance	Day 0, day 14, day28
Primary	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
Primary	The change of concentration of testosterone in blood	Fasting venous blood was sampled to measure concentrations of testosterone	Day 0, day 14, day28
Primary	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	The change of blood nitric oxide (NO)	Fasting venous blood was sampled to measure concentrations of nitric oxide	Day 0, day 14, day28
Secondary	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