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Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise

Primary Purpose

Exercise Addiction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Gojinsen® drinks
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Addiction

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. healthy male and female adults aged 20-25 years old .
  2. without heart, liver, kidney, endocrine or other major organic diseases).
  3. had at least 3 months experience in performing exercise

Exclusion Criteria:

1. BMI of the study subjects must be less than 25.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Gojinsen® drinks

    Arm Description

    consume 1 sachet per day for 14 day

    consume 1 sachet per day for 14 day

    Outcomes

    Primary Outcome Measures

    Endurance exercise performance testing
    the subjects arrived to the laboratory and wore the oxygen uptake mask of energy metabolism analyzer (Sensor Medics, Vmax29, USA) to measure the subjects' oxygen uptake
    rating of perceived exertion
    The Rated Perceived Exertion was measured during the treadmill exercise by Bruce Protocol, a gradual increase in the speed and the slope of the treadmill every 3 minutes.
    blood lactate
    fingertip capillary blood was placed in automated blood lactate analyzer
    Continuous attention performance test
    10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2021
    Last Updated
    November 22, 2021
    Sponsor
    TCI Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05129917
    Brief Title
    Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
    Official Title
    The Anti-fatigue Effect of Gojinsen® Drink
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    December 1, 2013 (Actual)
    Study Completion Date
    December 31, 2013 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main purpose of the present study is to determine the effects of acute and short-term (14 days) ginseng combined with branch chained amino acids supplementation on endurance exercise performance and the ability of anti-fatigue. In addition, this study also measured the performance of continuous attention during recovery period to examine the effect of supplementation on central fatigue.
    Detailed Description
    Muscle fatigue was a common problem after exercise. When fatigue occured, body functions were affected and changed. Changbai Mountain ginseng had higher anti-fatigue substances than general commercial ginseng. And recent studies had showed that the supplementation of branched chain amino acids (BCAA), including leucine, isoleucine and valine, can increase attention and reduce fatigue. However, its effect on Changbai Mountain ginseng combined with BCAA was still unclear. Subjects were allocated to Gojinsen® drinks and placebo group (1:1 ratio) for 14 days, and then examined by maximal oxygen consumption, time to exhaustion, rating of perceived exertion (RPE), oxygen saturation (SPO2) , blood lactate concentration, and continuous attention performance test (CPT II). The Gojinsen® group significant increased maximal oxygen consumption, time to exhaustion, and attention compared to placebo group. Moreover, the Gojinsen® group significant decreased lactate concentration and fatigue compared to placebo group. By this study, Gojinsen® drinks did not showed absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for people suffering from exercise fatigue.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exercise Addiction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    consume 1 sachet per day for 14 day
    Arm Title
    Gojinsen® drinks
    Arm Type
    Experimental
    Arm Description
    consume 1 sachet per day for 14 day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    consume 1 sachet per day for 14 day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gojinsen® drinks
    Intervention Description
    consume 1 sachet per day for 14 day
    Primary Outcome Measure Information:
    Title
    Endurance exercise performance testing
    Description
    the subjects arrived to the laboratory and wore the oxygen uptake mask of energy metabolism analyzer (Sensor Medics, Vmax29, USA) to measure the subjects' oxygen uptake
    Time Frame
    Execution on the 14th day
    Title
    rating of perceived exertion
    Description
    The Rated Perceived Exertion was measured during the treadmill exercise by Bruce Protocol, a gradual increase in the speed and the slope of the treadmill every 3 minutes.
    Time Frame
    Execution on the 14th day
    Title
    blood lactate
    Description
    fingertip capillary blood was placed in automated blood lactate analyzer
    Time Frame
    Execution on the 14th day
    Title
    Continuous attention performance test
    Description
    10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software
    Time Frame
    Execution on the 14th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy male and female adults aged 20-25 years old . without heart, liver, kidney, endocrine or other major organic diseases). had at least 3 months experience in performing exercise Exclusion Criteria: 1. BMI of the study subjects must be less than 25.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bo han Wu, Ph.D
    Organizational Affiliation
    Pingtung University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise

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