Maca in Healthy Subjects After Strenuous Endurance Exercise | NCT05779488

Studies
Maca in Healthy Subjects After Strenuous Endurance Exercise

NCT05779488

Sponsor

Taipei Medical University

Status

Unknown status

Last Update Posted

Mar 22, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

maca
placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MOST110-2410-H-038-013	Other Grant/Funding Number	National Science and Technology Council

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 22, 2023Actual

Name	Class
Panion & BF Biotech Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
maca group	Experimental		Dietary Supplement: maca
Placebo group	Placebo Comparator		Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maca	Dietary Supplement	2.25 g of Maca extract, twice per day for 12 weeks	maca group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of leukocyte		before exercise
Concentration of leukocyte		immediately after exercise
Concentration of leukocyte		2-hour after exercise
Concentration of leukocyte		4-hour after exercise
Concentration of leukocyte		24-hour after exercise
Concentration of neutrophil		before exercise
Concentration of neutrophil		immediately after exercise
Concentration of neutrophil		2-hour after exercise
Concentration of neutrophil		4-hour after exercise
Concentration of neutrophil		24-hour after exercise
Concentration of lymphocyte		beore exercise
Concentration of lymphocyte

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

The sample size is small due to the limited research funding. Additionally, considering the sports ability between men and women is significantly different, there would be a large standard deviation if we include both males and females. Thus our study includes male subjects only.

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided