NCT05129917

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 11, 2021

Last Update Submit

November 22, 2021

Conditions

Exercise Addiction

Outcome Measures

Primary Outcomes (4)

  • 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

    Execution on the 14th day

  • 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.

    Execution on the 14th day

  • blood lactate

    fingertip capillary blood was placed in automated blood lactate analyzer

    Execution on the 14th day

  • Continuous attention performance test

    10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software

    Execution on the 14th day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

consume 1 sachet per day for 14 day

Dietary Supplement: Placebo

Gojinsen® drinks

EXPERIMENTAL

consume 1 sachet per day for 14 day

Dietary Supplement: Gojinsen® drinks

Interventions

PlaceboDIETARY_SUPPLEMENT

consume 1 sachet per day for 14 day

Placebo
Gojinsen® drinksDIETARY_SUPPLEMENT

consume 1 sachet per day for 14 day

Gojinsen® drinks

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \. BMI of the study subjects must be less than 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Bo han Wu, Ph.D

    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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 22, 2021

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 31, 2013

Last Updated

December 6, 2021

Record last verified: 2021-11