- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05779488
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
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)
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 :
- 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 |
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:
|
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
Collaborators
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
University Hospital, Strasbourg, FranceICube LaboratoryNot yet recruitingHealthy | Healthy AdultFrance
-
Beijing Tide Pharmaceutical Co., LtdRecruitingHealthy | Healthy ParticipantsChina
Clinical Trials on maca
-
China Medical University HospitalNational Science and Technology Council; China Medical University, TaiwanCompletedHealthy | AthletesTaiwan
-
Taipei Medical UniversityNot yet recruiting
-
Massachusetts General HospitalCompletedDepression | Sexual DysfunctionUnited States
-
Massachusetts General HospitalNational Alliance for Research on Schizophrenia and DepressionTerminatedSexual Dysfunction | Bipolar DisorderUnited States
-
Massachusetts General HospitalNational Institutes of Health (NIH); National Center for Complementary and... and other collaboratorsCompletedAntidepressant Induced Sexual DysfunctionUnited States
-
National Taiwan Sport UniversityCompleted
-
Natural Wellness EgyptCompletedErectile DysfunctionEgypt
-
Universidade do Vale do SapucaiIrmandade da Santa Casa de Misericordia de Sao PauloUnknownSexual Dysfunction, PhysiologicalBrazil