A human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on improvement of exercise performance

12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder on the improvement of exercise performance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005109

Enrollment

100

Registered

2020-06-11

Start date

2020-02-06

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : • Gynostemma pentaphyllum (Thunb.) Makino leaf extract powder group: 2 capsules once daily, after breakfast for 12 weeks(700 mg/day, 450 mg/day for Gynostemma pentaphyllum (Thunb.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult males and females aged 19 to 60 at the screening test 2) Persons who have agreed to exercise test

Exclusion criteria

Exclusion criteria: 1) Participants who have problems in results about exercise test 2) Participants who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 35 kg/m^2 3) Participants who have taken medication or dietary supplements related to the improvement of exercise performance within 3 months prior to screening 4) Participants who have participated in the other human trials within 3 months before the screening test 5) Participants who are judged by the investigator to be ineligible to participate in the study due to other reasons including the results of laboratory test

Design outcomes

Primary

Measure	Time frame
Blood index related to exercise performance;Exercise test	—

Secondary

Measure	Time frame
Inorganic Phosphate;VO2max;Muscle mass;Blood index related to muscle damage;TAS; Total Antioxidant Status;eNOS(endothelial nitric oxide synthas);RPE; Rating of perceived exertion;Fatigue survey	—

Countries

Korea, Republic of

Contacts

Public ContactKYUNGLIM JOA

Inha University Hospital

Outcome results