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

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: Polygonatum kingianum extract drink

• Registration Number: NCT05877677
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study Start: 2023-05-18
• Study First Posted: 2023-05-26
• Primary Completion: 2023-06-17
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drink	Placebo drink	consume 1 bottle per day
Polygonatum kingianum extract drink	Polygonatum kingianum extract drink	consume 1 bottle per day

Primary Outcome Measures

Name	Time	Method
The change of blood PDE5 gene expression	Day 0, day 14, day28	Fasting venous blood was sampled to measure the expression of PDE5 gene
The change of aerobic endurance	Day 0, day 14, day28	3-min step test is used to assess aerobic endurance
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 concentration of testosterone in blood	Day 0, day 14, day28	Fasting venous blood was sampled to measure concentrations of testosterone

Secondary Outcome Measures

Name	Time	Method
The change of blood nitric oxide (NO)	Day 0, day 14, day28	Fasting venous blood was sampled to measure concentrations of nitric oxide
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.

Trial Locations

Locations (1)

National Pingtung University of Science and Technology; 🇨🇳 Pingtung, Taiwan