Maca in Healthy Subjects After Strenuous Endurance Exercise

NCT ID: NCT05779488

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
A double-blind, matched-pair study design

Study Groups

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maca group

Group Type EXPERIMENTAL

maca

Intervention Type DIETARY_SUPPLEMENT

2.25 g of Maca extract, twice per day for 12 weeks

Placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2.25 g of starch, twice per day for 12 weeks

Interventions

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maca

2.25 g of Maca extract, twice per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

2.25 g of starch, twice per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Panion & BF Biotech Inc.

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Panion & BF Biotech Inc.

INDUSTRY

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOST110-2410-H-038-013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202103118

Identifier Type: -

Identifier Source: org_study_id

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