Maca in Healthy Subjects After Strenuous Endurance Exercise

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05779488
• Other study ID #: N202103118
• Secondary ID: MOST110-2410-H-0
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• maca
2.25 g of Maca extract, twice per day for 12 weeks
• placebo
2.25 g of starch, twice per day for 12 weeks

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Panion & BF Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of leukocyte		before exercise
Primary	Concentration of leukocyte		immediately after exercise
Primary	Concentration of leukocyte		2-hour after exercise
Primary	Concentration of leukocyte		4-hour after exercise
Primary	Concentration of leukocyte		24-hour after exercise
Primary	Concentration of neutrophil		before exercise
Primary	Concentration of neutrophil		immediately after exercise
Primary	Concentration of neutrophil		2-hour after exercise
Primary	Concentration of neutrophil		4-hour after exercise
Primary	Concentration of neutrophil		24-hour after exercise
Primary	Concentration of lymphocyte		beore exercise
Primary	Concentration of lymphocyte		immediately after exercise
Primary	Concentration of lymphocyte		2-hour after exercise
Primary	Concentration of lymphocyte		4-hour after exercise
Primary	Concentration of lymphocyte		24-hour after exercise
Primary	Concentration of GSH		before exercise
Primary	Concentration of GSH		immediately after exercise
Primary	Concentration of GSH		2-hour after exercise
Primary	Concentration of GSH		4-hour after exercise
Primary	Concentration of GSH		24-hour after exercise
Primary	Concentration of CD4+		before exercise
Primary	Concentration of CD4+		immediately after exercise
Primary	Concentration of CD4+		2-hour after exercise
Primary	Concentration of CD4+		4-hour after exercise
Primary	Concentration of CD4+		24-hour after exercise
Primary	Concentration of CD8+		before exercise
Primary	Concentration of CD8+		immediately after exercise
Primary	Concentration of CD8+		2-hour after exercise
Primary	Concentration of CD8+		4-hour after exercise
Primary	Concentration of CD8+		24-hour after exercise
Primary	Concentration of CD19+		before exercise
Primary	Concentration of CD19+		immediately after exercise
Primary	Concentration of CD19+		2-hour after exercise
Primary	Concentration of CD19+		4-hour after exercise
Primary	Concentration of CD19+		24-hour after exercise
Primary	Concentration of CD56+		before after exercise
Primary	Concentration of CD56+		immediately after exercise
Primary	Concentration of CD56+		2-hour after exercise
Primary	Concentration of CD56+		4-hour after exercise
Primary	Concentration of CD56+		24-hour after exercise
Primary	IConcentration of GSSG		before exercise
Primary	Concentration of GSSG		immediately after exercise
Primary	Concentration of GSSG		2-hour after exercise
Primary	Concentration of GSSG		4-hour after exercise
Primary	Concentration of GSSG		24-hour after exercise
Primary	Concentration of CK-MB		before exercise
Primary	Concentration of CK-MB		2-hour after exercise
Primary	Concentration of CK-MB		4-hour after exercise
Primary	Concentration of CK-MB		24-hour after exercise
Primary	Concentration of CK-MB		immediately after exercise
Primary	Concentration of TNF-a		before exercise
Primary	Concentration of TNF-a		immediately after exercise
Primary	Concentration of TNF-a		2-hour after exercise
Primary	Concentration of TNF-a		4-hour after exercise
Primary	Concentration of TNF-a		24-hour after exercise
Primary	Concentration of IL-1ß		before exercise
Primary	Concentration of IL-1ß		immediately after exercise
Primary	Concentration of IL-1ß		2-hour after exercise
Primary	Concentration of IL-1ß		4-hour after exercise
Primary	Concentration of IL-1ß		24-hour after exercise
Primary	Concentration of IFN-?		before exercise
Primary	Concentration of IFN-?		immediately after exercise
Primary	Concentration of IFN-?		2-hour after exercise
Primary	Concentration of IFN-?		4-hour after exercise
Primary	Concentration of IFN-?		24-hour after exercise
Primary	Concentration of IL-2		before exercise
Primary	Concentration of IL-2		immediately after exercise
Primary	Concentration of IL-2		2-hour after exercise
Primary	Concentration of IL-2		4-hour after exercise
Primary	Concentration of IL-2		24-hour after exercise
Primary	Concentration of IL-4		before exercise
Primary	Concentration of IL-4		immediately after exercise
Primary	Concentration of IL-4		2-hour after exercise
Primary	Concentration of IL-4		4-hour after exercise
Primary	Concentration of IL-4		24-hour after exercise
Primary	Concentration of IL-8		before exercise
Primary	Concentration of IL-8		immediately after exercise
Primary	Concentration of IL-8		2-hour after exercise
Primary	Concentration of IL-8		4-hour after exercise
Primary	Concentration of IL-8		24-hour after exercise
Primary	Concentration of IL-10		before exercise
Primary	Concentration of IL-10		immediately after exercise
Primary	Concentration of IL-10		2-hour after exercise
Primary	Concentration of IL-10		4-hour after exercise
Primary	Concentration of IL-10		24-hour after exercise
Primary	Concentration of TBARS		before exercise
Primary	Concentration of TBARS		immediately after exercise
Primary	Concentration of TBARS		2-hour after exercise
Primary	Concentration of TBARS		4-hour after exercise
Primary	Concentration of TBARS		24-hour after exercise
Primary	Concentration of PC		before exercise
Primary	Concentration of PC		immediately after exercise
Primary	Concentration of PC		2-hour after exercise
Primary	Concentration of PC		4-hour after exercise
Primary	Concentration of PC		24-hour after exercise
Primary	Concentration of SOD		before exercise
Primary	Concentration of SOD		immediately after exercise
Primary	Concentration of SOD		2-hour after exercise
Primary	Concentration of SOD		4-hour after exercise
Primary	Concentration of SOD		24-hour after exercise
Primary	Concentration of catalase		before exercise
Primary	Concentration of catalase		immediately after exercise
Primary	Concentration of catalase		2-hour after exercise
Primary	Concentration of catalase		4-hour after exercise
Primary	Concentration of catalase		24-hour after exercise
Primary	Concentration of GPx		before exercise
Primary	Concentration of GPx		immediately after exercise
Primary	Concentration of GPx		2-hour after exercise
Primary	Concentration of GPx		4-hour after exercise
Primary	Concentration of GPx		24-hour after exercise
Primary	Concentration of CK		before exercise
Primary	Concentration of CK		immediately after exercise
Primary	Concentration of CK		2-hour after exercise
Primary	Concentration of CK		4-hour after exercise
Primary	Concentration of CK		24-hour after exercise
Primary	Concentration of LDH		before exercise
Primary	Concentration of LDH		immediately after exercise
Primary	Concentration of LDH		2-hour after exercise
Primary	Concentration of LDH		4-hour after exercise
Primary	Concentration of LDH		24-hour after exercise
Primary	Concentration of IL-6		before exercise
Primary	Concentration of IL-6		immediately after exercise
Primary	Concentration of IL-6		2-hour after exercise
Primary	Concentration of IL-6		4-hour after exercise
Primary	Concentration of IL-6		24-hour after exercise
Primary	Concentration of cTnI		before exercise
Primary	Concentration of cTnI		immediately after exercise
Primary	Concentration of cTnI		2-hour after exercise
Primary	Concentration of cTnI		4-hour after exercise
Primary	Concentration of cTnI		24-hour after exercise
Primary	Concentration of NT proBNP		before exercise
Primary	Concentration of NT proBNP		immediately after exercise
Primary	Concentration of NT proBNP		2-hour after exercise
Primary	Concentration of NT proBNP		4-hour after exercise
Primary	Concentration of NT proBNP		24-hour after exercise
Primary	Concentration of testosterone		before exercise
Primary	Concentration of testosterone		immediately after exercise
Primary	Concentration of testosterone		2-hour after exercise
Primary	Concentration of testosterone		4-hour after exercise
Primary	Concentration of testosterone		24-hour after exercise
Primary	Concentration of LH		before exercise
Primary	Concentration of LH		immediately after exercise
Primary	Concentration of LH		2-hour after exercise
Primary	Concentration of LH		4-hour after exercise
Primary	Concentration of LH		24-hour after exercise
Primary	Concentration of FSH		before exercise
Primary	Concentration of FSH		immediately after exercise
Primary	Concentration of FSH		2-hour after exercise
Primary	Concentration of FSH		4-hour after exercise
Primary	Concentration of FSH		24-hour after exercise
Primary	Concentration of NO		before exercise
Primary	Concentration of NO		immediately after exercise
Primary	Concentration of NO		2-hour after exercise
Primary	Concentration of NO		4-hour after exercise
Primary	Concentration of NO		24-hour after exercise
Primary	Concentration of GOT		before exercise
Primary	Concentration of GOT		immediately after exercise
Primary	Concentration of GOT		2-hour after exercise
Primary	Concentration of GOT		4-hour after exercise
Primary	Concentration of GOT		24-hour after exercise
Primary	Concentration of GPT		before exercise
Primary	Concentration of GPT		immediately after exercise
Primary	Concentration of GPT		2-hour after exercise
Primary	Concentration of GPT		4-hour after exercise
Primary	Concentration of GPT		24-hour after exercise
Primary	Concentration of BUN		before exercise
Primary	Concentration of BUN		immediately after exercise
Primary	Concentration of BUN		2-hour after exercise
Primary	Concentration of BUN		4-hour after exercise
Primary	Concentration of BUN		24-hour after exercise
Primary	Concentration of creatinine		before exercise
Primary	Concentration of creatinine		immediately after exercise
Primary	Concentration of creatinine		2-hour after exercise
Primary	Concentration of creatinine		4-hour after exercise
Primary	Concentration of creatinine		24-hour after exercise