Clinical trial NCT05779488: Maca in Healthy Subjects After Strenuous Endurance Exercise
Official title: Effects of Lepidium Meyenii (Maca) Extract Supplementation on Immune Function, Inflammatory Responses, Oxidative Stress After Strenuous Endurance Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Panion & BF Biotech Inc.
First posted: 2023-03-22
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of leukocyte
timeFrame: before exercise
measure: Concentration of leukocyte
timeFrame: immediately after exercise
measure: Concentration of leukocyte
timeFrame: 2-hour after exercise
measure: Concentration of leukocyte
timeFrame: 4-hour after exercise
measure: Concentration of leukocyte
timeFrame: 24-hour after exercise
measure: Concentration of neutrophil
timeFrame: before exercise
measure: Concentration of neutrophil
timeFrame: immediately after exercise
measure: Concentration of neutrophil
timeFrame: 2-hour after exercise
measure: Concentration of neutrophil
timeFrame: 4-hour after exercise
measure: Concentration of neutrophil
timeFrame: 24-hour after exercise
measure: Concentration of lymphocyte
timeFrame: beore exercise
measure: Concentration of lymphocyte
timeFrame: immediately after exercise
measure: Concentration of lymphocyte
timeFrame: 2-hour after exercise
measure: Concentration of lymphocyte
timeFrame: 4-hour after exercise
measure: Concentration of lymphocyte
timeFrame: 24-hour after exercise
measure: Concentration of GSH
timeFrame: before exercise
measure: Concentration of GSH
timeFrame: immediately after exercise
measure: Concentration of GSH
timeFrame: 2-hour after exercise
measure: Concentration of GSH
timeFrame: 4-hour after exercise
measure: Concentration of GSH
timeFrame: 24-hour after exercise
measure: Concentration of CD4+
timeFrame: before exercise
measure: Concentration of CD4+
timeFrame: immediately after exercise
measure: Concentration of CD4+
timeFrame: 2-hour after exercise
measure: Concentration of CD4+
timeFrame: 4-hour after exercise
measure: Concentration of CD4+
timeFrame: 24-hour after exercise
measure: Concentration of CD8+
timeFrame: before exercise
measure: Concentration of CD8+
timeFrame: immediately after exercise
measure: Concentration of CD8+
timeFrame: 2-hour after exercise
measure: Concentration of CD8+
timeFrame: 4-hour after exercise
measure: Concentration of CD8+
timeFrame: 24-hour after exercise
measure: Concentration of CD19+
timeFrame: before exercise
measure: Concentration of CD19+
timeFrame: immediately after exercise
measure: Concentration of CD19+
timeFrame: 2-hour after exercise
measure: Concentration of CD19+
timeFrame: 4-hour after exercise
measure: Concentration of CD19+
timeFrame: 24-hour after exercise
measure: Concentration of CD56+
timeFrame: before after exercise
measure: Concentration of CD56+
timeFrame: immediately after exercise
measure: Concentration of CD56+
timeFrame: 2-hour after exercise
measure: Concentration of CD56+
timeFrame: 4-hour after exercise
measure: Concentration of CD56+
timeFrame: 24-hour after exercise
measure: IConcentration of GSSG
timeFrame: before exercise
measure: Concentration of GSSG
timeFrame: immediately after exercise
measure: Concentration of GSSG
timeFrame: 2-hour after exercise
measure: Concentration of GSSG
timeFrame: 4-hour after exercise
measure: Concentration of GSSG
timeFrame: 24-hour after exercise
measure: Concentration of CK-MB
timeFrame: before exercise
measure: Concentration of CK-MB
timeFrame: 2-hour after exercise
measure: Concentration of CK-MB
timeFrame: 4-hour after exercise
measure: Concentration of CK-MB
timeFrame: 24-hour after exercise
measure: Concentration of CK-MB
timeFrame: immediately after exercise
measure: Concentration of TNF-α
timeFrame: before exercise
measure: Concentration of TNF-α
timeFrame: immediately after exercise
measure: Concentration of TNF-α
timeFrame: 2-hour after exercise
measure: Concentration of TNF-α
timeFrame: 4-hour after exercise
measure: Concentration of TNF-α
timeFrame: 24-hour after exercise
measure: Concentration of IL-1β
timeFrame: before exercise
measure: Concentration of IL-1β
timeFrame: immediately after exercise
measure: Concentration of IL-1β
timeFrame: 2-hour after exercise
measure: Concentration of IL-1β
timeFrame: 4-hour after exercise
measure: Concentration of IL-1β
timeFrame: 24-hour after exercise
measure: Concentration of IFN-γ
timeFrame: before exercise
measure: Concentration of IFN-γ
timeFrame: immediately after exercise
measure: Concentration of IFN-γ
timeFrame: 2-hour after exercise
measure: Concentration of IFN-γ
timeFrame: 4-hour after exercise
measure: Concentration of IFN-γ
timeFrame: 24-hour after exercise
measure: Concentration of IL-2
timeFrame: before exercise
measure: Concentration of IL-2
timeFrame: immediately after exercise
measure: Concentration of IL-2
timeFrame: 2-hour after exercise
measure: Concentration of IL-2
timeFrame: 4-hour after exercise
measure: Concentration of IL-2
timeFrame: 24-hour after exercise
measure: Concentration of IL-4
timeFrame: before exercise
measure: Concentration of IL-4
timeFrame: immediately after exercise
measure: Concentration of IL-4
timeFrame: 2-hour after exercise
measure: Concentration of IL-4
timeFrame: 4-hour after exercise
measure: Concentration of IL-4
timeFrame: 24-hour after exercise
measure: Concentration of IL-8
timeFrame: before exercise
measure: Concentration of IL-8
timeFrame: immediately after exercise
measure: Concentration of IL-8
timeFrame: 2-hour after exercise
measure: Concentration of IL-8
timeFrame: 4-hour after exercise
measure: Concentration of IL-8
timeFrame: 24-hour after exercise
measure: Concentration of IL-10
timeFrame: before exercise
measure: Concentration of IL-10
timeFrame: immediately after exercise
measure: Concentration of IL-10
timeFrame: 2-hour after exercise
measure: Concentration of IL-10
timeFrame: 4-hour after exercise
measure: Concentration of IL-10
timeFrame: 24-hour after exercise
measure: Concentration of TBARS
timeFrame: before exercise
measure: Concentration of TBARS
timeFrame: immediately after exercise
measure: Concentration of TBARS
timeFrame: 2-hour after exercise
measure: Concentration of TBARS
timeFrame: 4-hour after exercise
measure: Concentration of TBARS
timeFrame: 24-hour after exercise
measure: Concentration of PC
timeFrame: before exercise
measure: Concentration of PC
timeFrame: immediately after exercise
measure: Concentration of PC
timeFrame: 2-hour after exercise
measure: Concentration of PC
timeFrame: 4-hour after exercise
measure: Concentration of PC
timeFrame: 24-hour after exercise
measure: Concentration of SOD
timeFrame: before exercise
measure: Concentration of SOD
timeFrame: immediately after exercise
measure: Concentration of SOD
timeFrame: 2-hour after exercise
measure: Concentration of SOD
timeFrame: 4-hour after exercise
measure: Concentration of SOD
timeFrame: 24-hour after exercise
measure: Concentration of catalase
timeFrame: before exercise
measure: Concentration of catalase
timeFrame: immediately after exercise
measure: Concentration of catalase
timeFrame: 2-hour after exercise
measure: Concentration of catalase
timeFrame: 4-hour after exercise
measure: Concentration of catalase
timeFrame: 24-hour after exercise
measure: Concentration of GPx
timeFrame: before exercise
measure: Concentration of GPx
timeFrame: immediately after exercise
measure: Concentration of GPx
timeFrame: 2-hour after exercise
measure: Concentration of GPx
timeFrame: 4-hour after exercise
measure: Concentration of GPx
timeFrame: 24-hour after exercise
measure: Concentration of CK
timeFrame: before exercise
measure: Concentration of CK
timeFrame: immediately after exercise
measure: Concentration of CK
timeFrame: 2-hour after exercise
measure: Concentration of CK
timeFrame: 4-hour after exercise
measure: Concentration of CK
timeFrame: 24-hour after exercise
measure: Concentration of LDH
timeFrame: before exercise
measure: Concentration of LDH
timeFrame: immediately after exercise
measure: Concentration of LDH
timeFrame: 2-hour after exercise
measure: Concentration of LDH
timeFrame: 4-hour after exercise
measure: Concentration of LDH
timeFrame: 24-hour after exercise
measure: Concentration of IL-6
timeFrame: before exercise
measure: Concentration of IL-6
timeFrame: immediately after exercise
measure: Concentration of IL-6
timeFrame: 2-hour after exercise
measure: Concentration of IL-6
timeFrame: 4-hour after exercise
measure: Concentration of IL-6
timeFrame: 24-hour after exercise
measure: Concentration of cTnI
timeFrame: before exercise
measure: Concentration of cTnI
timeFrame: immediately after exercise
measure: Concentration of cTnI
timeFrame: 2-hour after exercise
measure: Concentration of cTnI
timeFrame: 4-hour after exercise
measure: Concentration of cTnI
timeFrame: 24-hour after exercise
measure: Concentration of NT proBNP
timeFrame: before exercise
measure: Concentration of NT proBNP
timeFrame: immediately after exercise
measure: Concentration of NT proBNP
timeFrame: 2-hour after exercise
measure: Concentration of NT proBNP
timeFrame: 4-hour after exercise
measure: Concentration of NT proBNP
timeFrame: 24-hour after exercise
measure: Concentration of testosterone
timeFrame: before exercise
measure: Concentration of testosterone
timeFrame: immediately after exercise
measure: Concentration of testosterone
timeFrame: 2-hour after exercise
measure: Concentration of testosterone
timeFrame: 4-hour after exercise
measure: Concentration of testosterone
timeFrame: 24-hour after exercise
measure: Concentration of LH
timeFrame: before exercise
measure: Concentration of LH
timeFrame: immediately after exercise
measure: Concentration of LH
timeFrame: 2-hour after exercise
measure: Concentration of LH
timeFrame: 4-hour after exercise
measure: Concentration of LH
timeFrame: 24-hour after exercise
measure: Concentration of FSH
timeFrame: before exercise
measure: Concentration of FSH
timeFrame: immediately after exercise
measure: Concentration of FSH
timeFrame: 2-hour after exercise
measure: Concentration of FSH
timeFrame: 4-hour after exercise
measure: Concentration of FSH
timeFrame: 24-hour after exercise
measure: Concentration of NO
timeFrame: before exercise
measure: Concentration of NO
timeFrame: immediately after exercise
measure: Concentration of NO
timeFrame: 2-hour after exercise
measure: Concentration of NO
timeFrame: 4-hour after exercise
measure: Concentration of NO
timeFrame: 24-hour after exercise
measure: Concentration of GOT
timeFrame: before exercise
measure: Concentration of GOT
timeFrame: immediately after exercise
measure: Concentration of GOT
timeFrame: 2-hour after exercise
measure: Concentration of GOT
timeFrame: 4-hour after exercise
measure: Concentration of GOT
timeFrame: 24-hour after exercise
measure: Concentration of GPT
timeFrame: before exercise
measure: Concentration of GPT
timeFrame: immediately after exercise
measure: Concentration of GPT
timeFrame: 2-hour after exercise
measure: Concentration of GPT
timeFrame: 4-hour after exercise
measure: Concentration of GPT
timeFrame: 24-hour after exercise
measure: Concentration of BUN
timeFrame: before exercise
measure: Concentration of BUN
timeFrame: immediately after exercise
measure: Concentration of BUN
timeFrame: 2-hour after exercise
measure: Concentration of BUN
timeFrame: 4-hour after exercise
measure: Concentration of BUN
timeFrame: 24-hour after exercise
measure: Concentration of creatinine
timeFrame: before exercise
measure: Concentration of creatinine
timeFrame: immediately after exercise
measure: Concentration of creatinine
timeFrame: 2-hour after exercise
measure: Concentration of creatinine
timeFrame: 4-hour after exercise
measure: Concentration of creatinine
timeFrame: 24-hour after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: