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Clinical Trial for Vespa Amino Acid Mixture (VAAM®)

Primary Purpose

Sports Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vespa amino acid mixture
Sponsored by
Shanghai Meiji Health Science and Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sports Injury focused on measuring Vespa amino acid mixture (VAAM®), Young athletes, Nutrition, lactic acid accumulation, Anaerobic metabolism, ATP, Sports damage

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Athletes from 16 to 18 years old;
  • Subjects underwent a physical examination before enrollment and showed no sign of illness or malaise.

Exclusion Criteria:

  • Subjects were smokers or ergogenic aid users;
  • Subjects had any metabolic, cardiovascular, renal, or liver diseases;
  • Subjects had psychiatric disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Subjects ingested VAAM® for 10 weeks

    Subjects ingested VAAM® for 6 weeks

    Subjects ingested nothing

    Arm Description

    Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 10 weeks, divided into different meter race including 1500-, 800- and 400-meter races.

    Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 6 weeks, divided into different meter race including 1500-, 800- and 400-meter races.

    Ten young athletes before ingesting Vespa amino acid mixture (VAAM®) , divided into different meter race including 1500-, 800- and 400-meter races.

    Outcomes

    Primary Outcome Measures

    change of running time scores at 10 weeks
    change of the plasma lactic acid clearance rate after running at 10 weeks
    change of red blood cells after running at 10 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2017
    Last Updated
    April 18, 2017
    Sponsor
    Shanghai Meiji Health Science and Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03121040
    Brief Title
    Clinical Trial for Vespa Amino Acid Mixture (VAAM®)
    Official Title
    Improved ATP Generation Efficiency for Younger Athletes by Ingestion of a Vespa Amino Acid Mixture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2, 2009 (Actual)
    Primary Completion Date
    July 16, 2009 (Actual)
    Study Completion Date
    July 22, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Meiji Health Science and Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. However, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. The efficiency of lactic acid metabolism is one of the most important reasons for endurance improvement. The purpose of this study was to evaluate the impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®) beverage on blood parameters that are related to fatigue, muscle damage and immunity in healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive required speed and strength running tests.
    Detailed Description
    The subjects were instructed to maintain their usual dietary habits in addition to drinking VAAM® (two cans every day) for 10 weeks. In detail, on the 6 days/week of supervised running tests, participants were instructed to consume one drink before their warm-up exercise and the other drink while running. During their sessions and without supervision (1 day/week), participants were also instructed to consume one drink in the morning after breakfast and the other drink in the evening after dinner. The subjects were divided into three groups for the running tests: 3 males were assigned to group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2, which involved training for the 800-meter race; and 1 male and 3 females were assigned to group 3, which involved training for the 400-meter race. The running exercises began with a 45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific races. The experimental procedure was conducted 6 days/week for 10 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sports Injury
    Keywords
    Vespa amino acid mixture (VAAM®), Young athletes, Nutrition, lactic acid accumulation, Anaerobic metabolism, ATP, Sports damage

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects ingested VAAM® for 10 weeks
    Arm Type
    Experimental
    Arm Description
    Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 10 weeks, divided into different meter race including 1500-, 800- and 400-meter races.
    Arm Title
    Subjects ingested VAAM® for 6 weeks
    Arm Type
    Experimental
    Arm Description
    Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 6 weeks, divided into different meter race including 1500-, 800- and 400-meter races.
    Arm Title
    Subjects ingested nothing
    Arm Type
    No Intervention
    Arm Description
    Ten young athletes before ingesting Vespa amino acid mixture (VAAM®) , divided into different meter race including 1500-, 800- and 400-meter races.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vespa amino acid mixture
    Other Intervention Name(s)
    VAAM®
    Intervention Description
    17 kinds of amino acids mixture in specific proportion
    Primary Outcome Measure Information:
    Title
    change of running time scores at 10 weeks
    Time Frame
    10 weeks
    Title
    change of the plasma lactic acid clearance rate after running at 10 weeks
    Time Frame
    10 weeks
    Title
    change of red blood cells after running at 10 weeks
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Athletes from 16 to 18 years old; Subjects underwent a physical examination before enrollment and showed no sign of illness or malaise. Exclusion Criteria: Subjects were smokers or ergogenic aid users; Subjects had any metabolic, cardiovascular, renal, or liver diseases; Subjects had psychiatric disorders.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Trial for Vespa Amino Acid Mixture (VAAM®)

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