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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03888196
Other study ID # Nutren-Disanta 0012018
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 1, 2016
Est. completion date January 15, 2019

Study information

Verified date April 2019
Source Universitat de Lleida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. ginseng root extract supplementation may promote fat oxidation, increase hepatic glycogen levels and produce a glycogen-sparing and antifatigue effect during exercise in swimming rats. Notwithstanding, although there is some evidence of P. ginseng effects in humans, no evidence has been obtained respect to its supplementation in human sport performance. The aim of this study is to assess the effect of P ginseng extract supplementation on the lipid metabolism and sport performance in male endurance runners. For this purpose, the effect of supplementation for 2 weeks of 500 mg/day of P. ginseng will be evaluated in a sub-maximal physical stress test. Variables of lipid metabolism, energy consumption, fatigue, and endurance will be determined.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 15, 2019
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Athletic men of aerobic type, who participate in a supervised training as a previous step to the accomplishment of competitions

- Which their age is older than 18 years

- Training superior or equal to 3 days per week and that these workouts are stable during the intervention.

Exclusion Criteria:

- Athletes with high blood pressure, with pharmacological treatment for hypercholesterolemia, diabetes, any psychiatric illness

- Athletes who practice sports without having the objective of increasing sports performance

- Athletes who use some type of ergogenic sport supplementation looking to optimize any aspect related to the sport.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Panax Ginseng Supplementation
500 mg/day of Panax Ginseng
Placebo Supplementation
500 mg/day of Cellulose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universitat de Lleida

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline plasmatic Total Lipids at 2 weeks Total Lipids in the plasma are measured in mg / dL 2 weeks
Primary Change from baseline plasmatic Triglycerides at 2 weeks Triglycerides in the plasma are measured in mg / dL 2 weeks
Primary Change from baseline Respiratory Exchange Rate at 2 weeks To quantify the amount of Oxygen consumed and the amount of carbon dioxide produced. (mL/Kg/Min) 2 weeks
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