Maca in Healthy Subjects After Strenuous Endurance Exercise

March 9, 2023 updated by: Taipei Medical University

Effects of Lepidium Meyenii (Maca) Extract Supplementation on Immune Function, Inflammatory Responses, Oxidative Stress After Strenuous Endurance Exercise

The aim of this study is to investigate Lepidium meyenii (Maca) extract supplementation on exercise-induced responses of the biochemical, and physiological parameters.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Thirty healthy male participants were divided into Maca group (2.25 g of Maca extract, twice per day for 12 weeks) and placebo group (n = 15). All participants conducted a graded exercise test on treadmill to determine the maximal oxygen consumption (VO2max) before and after supplementation, and the speed equivalent to 70% VO2max was conducted for an exhaustive endurance exercise test by treadmill for 1 hours, followed by 90% VO2max until exhaustion.The time to exhaustion, peak oxygen consumption, maximal heart rate and average heart rate will be recorded during the exercise period. Venous blood samples will be drawn before, immediately after, 2-hour after, 4-hour after, and 24-hour after the exhaustive endurance exercise test. Data was analyzed by Two-way mixed design ANOVA.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 110
        • Taipei Medical University

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

-

The volunteers included have conditions as stated below :

  1. male adult whose no history of cardiovascular, liver, kidney and diabetes disease
  2. no acute sport injury
  3. did not participated in any clinical trials or research in the last 3 months before our experiment
  4. no supplements were taken during the experimental period
  5. were requested to maintain their regular daily life style and avoid alcohol intake

Exclusion Criteria:

-

The volunteers were excluded if they have the situation stated below:

  1. history of cardiovascular, liver, kidney and diabetes disease
  2. acute sport injury
  3. participated in any clinical trials or experimental research in the last 3 months before our experiment
  4. taking supplement during the experimental period
  5. did not maintain their regular eating habit or drink alcohol

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
2.25 g of starch, twice per day for 12 weeks
Experimental: maca group
2.25 g of Maca extract, twice per day for 12 weeks
Other Names:
  • Panion & BF Biotech Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of leukocyte
Time Frame: before exercise
before exercise
Concentration of leukocyte
Time Frame: immediately after exercise
immediately after exercise
Concentration of leukocyte
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of leukocyte
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of leukocyte
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of neutrophil
Time Frame: before exercise
before exercise
Concentration of neutrophil
Time Frame: immediately after exercise
immediately after exercise
Concentration of neutrophil
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of neutrophil
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of neutrophil
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of lymphocyte
Time Frame: beore exercise
beore exercise
Concentration of lymphocyte
Time Frame: immediately after exercise
immediately after exercise
Concentration of lymphocyte
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of lymphocyte
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of lymphocyte
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of GSH
Time Frame: before exercise
before exercise
Concentration of GSH
Time Frame: immediately after exercise
immediately after exercise
Concentration of GSH
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GSH
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GSH
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD4+
Time Frame: before exercise
before exercise
Concentration of CD4+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD4+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD4+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD4+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD8+
Time Frame: before exercise
before exercise
Concentration of CD8+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD8+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD8+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD8+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD19+
Time Frame: before exercise
before exercise
Concentration of CD19+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD19+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD19+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD19+
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CD56+
Time Frame: before after exercise
before after exercise
Concentration of CD56+
Time Frame: immediately after exercise
immediately after exercise
Concentration of CD56+
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CD56+
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CD56+
Time Frame: 24-hour after exercise
24-hour after exercise
IConcentration of GSSG
Time Frame: before exercise
before exercise
Concentration of GSSG
Time Frame: immediately after exercise
immediately after exercise
Concentration of GSSG
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GSSG
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GSSG
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CK-MB
Time Frame: before exercise
before exercise
Concentration of CK-MB
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CK-MB
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CK-MB
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CK-MB
Time Frame: immediately after exercise
immediately after exercise
Concentration of TNF-α
Time Frame: before exercise
before exercise
Concentration of TNF-α
Time Frame: immediately after exercise
immediately after exercise
Concentration of TNF-α
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of TNF-α
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of TNF-α
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-1β
Time Frame: before exercise
before exercise
Concentration of IL-1β
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-1β
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-1β
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-1β
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IFN-γ
Time Frame: before exercise
before exercise
Concentration of IFN-γ
Time Frame: immediately after exercise
immediately after exercise
Concentration of IFN-γ
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IFN-γ
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IFN-γ
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-2
Time Frame: before exercise
before exercise
Concentration of IL-2
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-2
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-2
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-2
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-4
Time Frame: before exercise
before exercise
Concentration of IL-4
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-4
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-4
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-4
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-8
Time Frame: before exercise
before exercise
Concentration of IL-8
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-8
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-8
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-8
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-10
Time Frame: before exercise
before exercise
Concentration of IL-10
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-10
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-10
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-10
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of TBARS
Time Frame: before exercise
before exercise
Concentration of TBARS
Time Frame: immediately after exercise
immediately after exercise
Concentration of TBARS
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of TBARS
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of TBARS
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of PC
Time Frame: before exercise
before exercise
Concentration of PC
Time Frame: immediately after exercise
immediately after exercise
Concentration of PC
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of PC
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of PC
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of SOD
Time Frame: before exercise
before exercise
Concentration of SOD
Time Frame: immediately after exercise
immediately after exercise
Concentration of SOD
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of SOD
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of SOD
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of catalase
Time Frame: before exercise
before exercise
Concentration of catalase
Time Frame: immediately after exercise
immediately after exercise
Concentration of catalase
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of catalase
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of catalase
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of GPx
Time Frame: before exercise
before exercise
Concentration of GPx
Time Frame: immediately after exercise
immediately after exercise
Concentration of GPx
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GPx
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GPx
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of CK
Time Frame: before exercise
before exercise
Concentration of CK
Time Frame: immediately after exercise
immediately after exercise
Concentration of CK
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of CK
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of CK
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of LDH
Time Frame: before exercise
before exercise
Concentration of LDH
Time Frame: immediately after exercise
immediately after exercise
Concentration of LDH
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of LDH
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of LDH
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of IL-6
Time Frame: before exercise
before exercise
Concentration of IL-6
Time Frame: immediately after exercise
immediately after exercise
Concentration of IL-6
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of IL-6
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of IL-6
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of cTnI
Time Frame: before exercise
before exercise
Concentration of cTnI
Time Frame: immediately after exercise
immediately after exercise
Concentration of cTnI
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of cTnI
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of cTnI
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of NT proBNP
Time Frame: before exercise
before exercise
Concentration of NT proBNP
Time Frame: immediately after exercise
immediately after exercise
Concentration of NT proBNP
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of NT proBNP
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of NT proBNP
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of testosterone
Time Frame: before exercise
before exercise
Concentration of testosterone
Time Frame: immediately after exercise
immediately after exercise
Concentration of testosterone
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of testosterone
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of testosterone
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of LH
Time Frame: before exercise
before exercise
Concentration of LH
Time Frame: immediately after exercise
immediately after exercise
Concentration of LH
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of LH
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of LH
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of FSH
Time Frame: before exercise
before exercise
Concentration of FSH
Time Frame: immediately after exercise
immediately after exercise
Concentration of FSH
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of FSH
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of FSH
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of NO
Time Frame: before exercise
before exercise
Concentration of NO
Time Frame: immediately after exercise
immediately after exercise
Concentration of NO
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of NO
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of NO
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of GOT
Time Frame: before exercise
before exercise
Concentration of GOT
Time Frame: immediately after exercise
immediately after exercise
Concentration of GOT
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GOT
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GOT
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of GPT
Time Frame: before exercise
before exercise
Concentration of GPT
Time Frame: immediately after exercise
immediately after exercise
Concentration of GPT
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of GPT
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of GPT
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of BUN
Time Frame: before exercise
before exercise
Concentration of BUN
Time Frame: immediately after exercise
immediately after exercise
Concentration of BUN
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of BUN
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of BUN
Time Frame: 24-hour after exercise
24-hour after exercise
Concentration of creatinine
Time Frame: before exercise
before exercise
Concentration of creatinine
Time Frame: immediately after exercise
immediately after exercise
Concentration of creatinine
Time Frame: 2-hour after exercise
2-hour after exercise
Concentration of creatinine
Time Frame: 4-hour after exercise
4-hour after exercise
Concentration of creatinine
Time Frame: 24-hour after exercise
24-hour after exercise

Collaborators and Investigators

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

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)

April 14, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • N202103118
  • MOST110-2410-H-038-013 (Other Grant/Funding Number: National Science and Technology Council)

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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