Maca in Healthy Subjects After Strenuous Endurance Exercise

Study Overview
=================
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.

Official Title
-----------------
Effects of Lepidium Meyenii (Maca) Extract Supplementation on Immune Function, Inflammatory Responses, Oxidative Stress After Strenuous Endurance Exercise

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: maca
* Dietary Supplement: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maca group<br> | Dietary Supplement: maca<br>* 2.25 g of Maca extract, twice per day for 12 weeks<br>* Other names: Panion & BF Biotech Inc.;|
| Placebo Comparator: Placebo group<br> | Dietary Supplement: placebo<br>* 2.25 g of starch, twice per day for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |  | 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 |