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

Healthy

Intervention / Treatment

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)

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

Taiwan
- - 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 :

male adult whose no history of cardiovascular, liver, kidney and diabetes disease
no acute sport injury
did not participated in any clinical trials or research in the last 3 months before our experiment
no supplements were taken during the experimental period
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:

history of cardiovascular, liver, kidney and diabetes disease
acute sport injury
participated in any clinical trials or experimental research in the last 3 months before our experiment
taking supplement during the experimental period
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 Participant Group / Arm A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.	Intervention / Treatment Intervention / Treatment A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group	Dietary supplement: placebo 2.25 g of starch, twice per day for 12 weeks
Experimental: maca group	Dietary supplement: maca 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.

Sponsor

Taipei Medical University

Collaborators

Panion & BF Biotech Inc.

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

Studies a U.S. FDA-regulated device product

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy

Clinical Trials on maca

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations