Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice. (GinsengRun)

April 30, 2019 updated by: José Serrano, Universitat de Lleida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
500 mg/day of Panax Ginseng. 2 weeks treatment
Dietary supplement: Panax Ginseng Supplementation
500 mg/day of Panax Ginseng
Placebo Comparator: Control Group
500 mg/day of Celulose. 2 weeks treatment
Dietary supplement: Placebo Supplementation
500 mg/day of Cellulose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Investigators

  • Study Chair: Jose D Serrano, Dr, Universitat de Lleida
  • Study Director: Alba Naudí, Dra, Universitat de Lleida
  • Principal Investigator: Cristian D Hernandez, PhD Student, Universitat de Lleida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nutren-Disanta 0012018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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