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Completed

NCT Number: NCT05877677

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

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Pingtung University of Science and Technology

Pingtung City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 bottle per day

Polygonatum kingianum extract drink

Dietary Supplement

consume 1 bottle per day

Other names: Dragon Power® Polygonatum kingianum extract drink

Primary outcomes

  1. The change of aerobic endurance

    Time frame: Day 0, day 14, day28

    3-min step test is used to assess aerobic endurance

  2. The change of continuous attention performance

    Time frame: Day 0, day 14, day28

    Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance

  3. The change of concentration of testosterone in blood

    Time frame: Day 0, day 14, day28

    Fasting venous blood was sampled to measure concentrations of testosterone

  4. The change of blood PDE5 gene expression

    Time frame: Day 0, day 14, day28

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

Secondary outcomes

  1. The change of blood nitric oxide (NO)

    Time frame: Day 0, day 14, day28

    Fasting venous blood was sampled to measure concentrations of nitric oxide

  2. The change of self-assessment fatigue condition

    Time frame: 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.

Other outcomes

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

    Time frame: Day 0, day 14, day28

    Fasting venous blood was sampled to measure the concentration of liver function biomarkers- Aspartate amino transferase (AST), Alanine amino transferase (ALT).

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

    Time frame: Day 0, day 14, day28

    Fasting venous blood was sampled to measure the concentration of renal function biomarkers- Blood Urea Nitrogen (BUN), creatinine.

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

    Time frame: Day 0, day 14, day28

    Fasting venous blood was sampled to measure lipid profiles- total cholesterol, Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C), triglyceride.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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