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

NCT05877677 | Completed

• 1 other identifier: 23-027-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue

Outcome Measures

Primary Outcomes (4)

• 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 concentration of testosterone in blood

  Fasting venous blood was sampled to measure concentrations of testosterone

  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

Secondary Outcomes (2)

• The change of blood nitric oxide (NO)

  Day 0, day 14, day28

• The change of self-assessment fatigue condition

  Day 0, day 14, day28

Other Outcomes (3)

• The change of concentrations of liver function biomarkers (AST, ALT) in blood

  Day 0, day 14, day28

• The change of concentrations of renal function biomarkers (BUN, creatinine) in blood

  Day 0, day 14, day28

• The change of concentrations of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride)

  Day 0, day 14, day28

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

consume 1 bottle per day

Dietary Supplement: Placebo drink

Polygonatum kingianum extract drink

EXPERIMENTAL

consume 1 bottle per day

Dietary Supplement: Polygonatum kingianum extract drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Placebo drink

Polygonatum kingianum extract drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Also known as: Dragon Power® Polygonatum kingianum extract drink

Polygonatum kingianum extract drink

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Pingtung University of Science and Technology

Pingtung City, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo-han Wu

  National Pingtung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: May 18, 2023
• Primary Completion: June 17, 2023
• Study Completion: July 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

TW (1)