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

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

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Polygonatum kingianum extract drink

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Pingtung, Taiwan
    • National Pingtung University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink; consume 1 bottle per day	Dietary supplement: Placebo drink; consume 1 bottle per day
Experimental: Polygonatum kingianum extract drink; consume 1 bottle per day	Dietary supplement: Polygonatum kingianum extract drink; consume 1 bottle per day; Other Names: Dragon Power® Polygonatum kingianum extract drink

What is the study measuring?

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 blood PDE5 gene expression	Fasting venous blood was sampled to measure the expression of PDE5 gene	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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Bo-han Wu, National Pingtung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): June 17, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 23-027-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No