NCT05779488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

February 20, 2023

Last Update Submit

March 9, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (175)

  • 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

    immediately after exercise

  • Concentration of lymphocyte

    2-hour after exercise

  • Concentration of lymphocyte

    4-hour after exercise

  • Concentration of lymphocyte

    24-hour after exercise

  • Concentration of GSH

    before exercise

  • Concentration of GSH

    immediately after exercise

  • Concentration of GSH

    2-hour after exercise

  • Concentration of GSH

    4-hour after exercise

  • Concentration of GSH

    24-hour after exercise

  • Concentration of CD4+

    before exercise

  • Concentration of CD4+

    immediately after exercise

  • Concentration of CD4+

    2-hour after exercise

  • Concentration of CD4+

    4-hour after exercise

  • Concentration of CD4+

    24-hour after exercise

  • Concentration of CD8+

    before exercise

  • Concentration of CD8+

    immediately after exercise

  • Concentration of CD8+

    2-hour after exercise

  • Concentration of CD8+

    4-hour after exercise

  • Concentration of CD8+

    24-hour after exercise

  • Concentration of CD19+

    before exercise

  • Concentration of CD19+

    immediately after exercise

  • Concentration of CD19+

    2-hour after exercise

  • Concentration of CD19+

    4-hour after exercise

  • Concentration of CD19+

    24-hour after exercise

  • Concentration of CD56+

    before after exercise

  • Concentration of CD56+

    immediately after exercise

  • Concentration of CD56+

    2-hour after exercise

  • Concentration of CD56+

    4-hour after exercise

  • Concentration of CD56+

    24-hour after exercise

  • IConcentration of GSSG

    before exercise

  • Concentration of GSSG

    immediately after exercise

  • Concentration of GSSG

    2-hour after exercise

  • Concentration of GSSG

    4-hour after exercise

  • Concentration of GSSG

    24-hour after exercise

  • Concentration of CK-MB

    before exercise

  • Concentration of CK-MB

    2-hour after exercise

  • Concentration of CK-MB

    4-hour after exercise

  • Concentration of CK-MB

    24-hour after exercise

  • Concentration of CK-MB

    immediately after exercise

  • Concentration of TNF-α

    before exercise

  • Concentration of TNF-α

    immediately after exercise

  • Concentration of TNF-α

    2-hour after exercise

  • Concentration of TNF-α

    4-hour after exercise

  • Concentration of TNF-α

    24-hour after exercise

  • Concentration of IL-1β

    before exercise

  • Concentration of IL-1β

    immediately after exercise

  • Concentration of IL-1β

    2-hour after exercise

  • Concentration of IL-1β

    4-hour after exercise

  • Concentration of IL-1β

    24-hour after exercise

  • Concentration of IFN-γ

    before exercise

  • Concentration of IFN-γ

    immediately after exercise

  • Concentration of IFN-γ

    2-hour after exercise

  • Concentration of IFN-γ

    4-hour after exercise

  • Concentration of IFN-γ

    24-hour after exercise

  • Concentration of IL-2

    before exercise

  • Concentration of IL-2

    immediately after exercise

  • Concentration of IL-2

    2-hour after exercise

  • Concentration of IL-2

    4-hour after exercise

  • Concentration of IL-2

    24-hour after exercise

  • Concentration of IL-4

    before exercise

  • Concentration of IL-4

    immediately after exercise

  • Concentration of IL-4

    2-hour after exercise

  • Concentration of IL-4

    4-hour after exercise

  • Concentration of IL-4

    24-hour after exercise

  • Concentration of IL-8

    before exercise

  • Concentration of IL-8

    immediately after exercise

  • Concentration of IL-8

    2-hour after exercise

  • Concentration of IL-8

    4-hour after exercise

  • Concentration of IL-8

    24-hour after exercise

  • Concentration of IL-10

    before exercise

  • Concentration of IL-10

    immediately after exercise

  • Concentration of IL-10

    2-hour after exercise

  • Concentration of IL-10

    4-hour after exercise

  • Concentration of IL-10

    24-hour after exercise

  • Concentration of TBARS

    before exercise

  • Concentration of TBARS

    immediately after exercise

  • Concentration of TBARS

    2-hour after exercise

  • Concentration of TBARS

    4-hour after exercise

  • Concentration of TBARS

    24-hour after exercise

  • Concentration of PC

    before exercise

  • Concentration of PC

    immediately after exercise

  • Concentration of PC

    2-hour after exercise

  • Concentration of PC

    4-hour after exercise

  • Concentration of PC

    24-hour after exercise

  • Concentration of SOD

    before exercise

  • Concentration of SOD

    immediately after exercise

  • Concentration of SOD

    2-hour after exercise

  • Concentration of SOD

    4-hour after exercise

  • Concentration of SOD

    24-hour after exercise

  • Concentration of catalase

    before exercise

  • Concentration of catalase

    immediately after exercise

  • Concentration of catalase

    2-hour after exercise

  • Concentration of catalase

    4-hour after exercise

  • Concentration of catalase

    24-hour after exercise

  • Concentration of GPx

    before exercise

  • Concentration of GPx

    immediately after exercise

  • Concentration of GPx

    2-hour after exercise

  • Concentration of GPx

    4-hour after exercise

  • Concentration of GPx

    24-hour after exercise

  • Concentration of CK

    before exercise

  • Concentration of CK

    immediately after exercise

  • Concentration of CK

    2-hour after exercise

  • Concentration of CK

    4-hour after exercise

  • Concentration of CK

    24-hour after exercise

  • Concentration of LDH

    before exercise

  • Concentration of LDH

    immediately after exercise

  • Concentration of LDH

    2-hour after exercise

  • Concentration of LDH

    4-hour after exercise

  • Concentration of LDH

    24-hour after exercise

  • Concentration of IL-6

    before exercise

  • Concentration of IL-6

    immediately after exercise

  • Concentration of IL-6

    2-hour after exercise

  • Concentration of IL-6

    4-hour after exercise

  • Concentration of IL-6

    24-hour after exercise

  • Concentration of cTnI

    before exercise

  • Concentration of cTnI

    immediately after exercise

  • Concentration of cTnI

    2-hour after exercise

  • Concentration of cTnI

    4-hour after exercise

  • Concentration of cTnI

    24-hour after exercise

  • Concentration of NT proBNP

    before exercise

  • Concentration of NT proBNP

    immediately after exercise

  • Concentration of NT proBNP

    2-hour after exercise

  • Concentration of NT proBNP

    4-hour after exercise

  • Concentration of NT proBNP

    24-hour after exercise

  • Concentration of testosterone

    before exercise

  • Concentration of testosterone

    immediately after exercise

  • Concentration of testosterone

    2-hour after exercise

  • Concentration of testosterone

    4-hour after exercise

  • Concentration of testosterone

    24-hour after exercise

  • Concentration of LH

    before exercise

  • Concentration of LH

    immediately after exercise

  • Concentration of LH

    2-hour after exercise

  • Concentration of LH

    4-hour after exercise

  • Concentration of LH

    24-hour after exercise

  • Concentration of FSH

    before exercise

  • Concentration of FSH

    immediately after exercise

  • Concentration of FSH

    2-hour after exercise

  • Concentration of FSH

    4-hour after exercise

  • Concentration of FSH

    24-hour after exercise

  • Concentration of NO

    before exercise

  • Concentration of NO

    immediately after exercise

  • Concentration of NO

    2-hour after exercise

  • Concentration of NO

    4-hour after exercise

  • Concentration of NO

    24-hour after exercise

  • Concentration of GOT

    before exercise

  • Concentration of GOT

    immediately after exercise

  • Concentration of GOT

    2-hour after exercise

  • Concentration of GOT

    4-hour after exercise

  • Concentration of GOT

    24-hour after exercise

  • Concentration of GPT

    before exercise

  • Concentration of GPT

    immediately after exercise

  • Concentration of GPT

    2-hour after exercise

  • Concentration of GPT

    4-hour after exercise

  • Concentration of GPT

    24-hour after exercise

  • Concentration of BUN

    before exercise

  • Concentration of BUN

    immediately after exercise

  • Concentration of BUN

    2-hour after exercise

  • Concentration of BUN

    4-hour after exercise

  • Concentration of BUN

    24-hour after exercise

  • Concentration of creatinine

    before exercise

  • Concentration of creatinine

    immediately after exercise

  • Concentration of creatinine

    2-hour after exercise

  • Concentration of creatinine

    4-hour after exercise

  • Concentration of creatinine

    24-hour after exercise

Study Arms (2)

maca group

EXPERIMENTAL
Dietary Supplement: maca

Placebo group

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

macaDIETARY_SUPPLEMENT

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

Also known as: Panion & BF Biotech Inc.
maca group
placeboDIETARY_SUPPLEMENT

2.25 g of starch, twice per day for 12 weeks

Placebo group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Interventions

MacA protein, E coli

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A double-blind, matched-pair study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 22, 2023

Study Start

April 14, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-02

Locations

TW(1)