Back to resultsThe Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Primary Purpose
Fatigue
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Polygonatum kingianum extract drink
Sponsored by
About this trial
This is an interventional other trial for Fatigue
Eligibility Criteria
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.
Sites / Locations
- National Pingtung University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
Polygonatum kingianum extract drink
Arm Description
consume 1 bottle per day
consume 1 bottle per day
Outcomes
Primary Outcome Measures
The change of aerobic endurance
3-min step test is used to assess aerobic endurance
The change of continuous attention performance
Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance
The change of concentration of testosterone in blood
Fasting venous blood was sampled to measure concentrations of testosterone
The change of blood PDE5 gene expression
Fasting venous blood was sampled to measure the expression of PDE5 gene
Secondary Outcome Measures
The change of blood nitric oxide (NO)
Fasting venous blood was sampled to measure concentrations of nitric oxide
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05877677
Brief Title
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Official Title
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
June 17, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Description
consume 1 bottle per day
Arm Title
Polygonatum kingianum extract drink
Arm Type
Experimental
Arm Description
consume 1 bottle per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 1 bottle per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Polygonatum kingianum extract drink
Other Intervention Name(s)
Dragon Power® Polygonatum kingianum extract drink
Intervention Description
consume 1 bottle per day
Primary Outcome Measure Information:
Title
The change of aerobic endurance
Description
3-min step test is used to assess aerobic endurance
Time Frame
Day 0, day 14, day28
Title
The change of continuous attention performance
Description
Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance
Time Frame
Day 0, day 14, day28
Title
The change of concentration of testosterone in blood
Description
Fasting venous blood was sampled to measure concentrations of testosterone
Time Frame
Day 0, day 14, day28
Title
The change of blood PDE5 gene expression
Description
Fasting venous blood was sampled to measure the expression of PDE5 gene
Time Frame
Day 0, day 14, day28
Secondary Outcome Measure Information:
Title
The change of blood nitric oxide (NO)
Description
Fasting venous blood was sampled to measure concentrations of nitric oxide
Time Frame
Day 0, day 14, day28
Title
The change of self-assessment fatigue condition
Description
A 10 point likert scale was utilized to evaluate fatigue condition. The higher the score, the higher the fatigue level.
Time Frame
Day 0, day 14, day28
Other Pre-specified Outcome Measures:
Title
The change of concentrations of liver function biomarkers (AST, ALT) in blood
Description
Fasting venous blood was sampled to measure the concentration of liver function biomarkers- Aspartate amino transferase (AST), Alanine amino transferase (ALT).
Time Frame
Day 0, day 14, day28
Title
The change of concentrations of renal function biomarkers (BUN, creatinine) in blood
Description
Fasting venous blood was sampled to measure the concentration of renal function biomarkers- Blood Urea Nitrogen (BUN), creatinine.
Time Frame
Day 0, day 14, day28
Title
The change of concentrations of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride)
Description
Fasting venous blood was sampled to measure lipid profiles- total cholesterol, Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C), triglyceride.
Time Frame
Day 0, day 14, day28
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo-han Wu
Organizational Affiliation
National Pingtung University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Pingtung University of Science and Technology
City
Pingtung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
We'll reach out to this number within 24 hrs