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

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05877677
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
7.5
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo drink
  • Dietary Supplement: Polygonatum kingianum extract drink
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Anticipated Study Start Date :
May 18, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change of aerobic endurance [Day 0, day 14, day28]

      3-min step test is used to assess aerobic endurance

    2. 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

    3. The change of blood testosterone [Day 0, day 14, day28]

      Fasting venous blood was sampled to measure concentrations of testosterone

    4. The change of blood PDE5 gene expression [Day 0, day 14, day28]

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

    Secondary Outcome Measures

    1. The change of blood nitric oxide (NO) [Day 0, day 14, day28]

      Fasting venous blood was sampled to measure concentrations of nitric oxide

    2. The change of self-assessment fatigue condition [Day 0, day 14, day28]

      A self-assessment questionnaire was collected to evaluate fatigue condition

    Other Outcome Measures

    1. The change of liver function biomarkers (AST, ALT) of blood [Day 0, day 14, day28]

      Fasting venous blood was sampled to measure liver function biomarkers.

    2. The change of renal function biomarkers (BUN, creatinine) of blood [Day 0, day 14, day28]

      Fasting venous blood was sampled to measure renal function biomarkers.

    3. The change of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride) [Day 0, day 14, day28]

      Fasting venous blood was sampled to measure lipid profiles.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Pingtung University of Science and Technology Pingtung Taiwan

    Sponsors and Collaborators

    • TCI Co., Ltd.

    Investigators

    • Principal Investigator: Bo-han Wu, National Pingtung University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCI Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05877677
    Other Study ID Numbers:
    • 23-027-A
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of May 26, 2023