Maca Extract in Sexual Dysfunction Male

Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion

The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Dysfunction Male
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Maca

Detailed Description

All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Ta Yang, Doctorate; Phone Number: 2275 886-2-27361661; Email: yangrugby@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. evaluated as sexual dysfunction for more than three months by physician
2. international index of erectile function (IIEF) score is less than or equal to 21
3. erectile hardness score (EHS) score is less than or equal to 3
4. aged over 18 years old

Exclusion Criteria:

1. unable to cooperate with the course of the treatment
2. suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
3. had Radical Prostatectomy (total removal of the prostate gland)
4. suffering from active tumors in the prostate or pelvic area
5. suffering from Hypogonadism
6. anatomical deformation of the penis
7. men with penile prosthesis
8. suffering from psychotic disorder (manic disorder, chronic depression, etc.)
9. suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
10. using Permanent pacemaker
11. considered unsuitable to participate in this experiment according to the doctor
12. alcohol or drug abuse

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Dietary supplement: Placebo; Placebo
Experimental: Maca group	Dietary supplement: Maca; 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IIEF-5 score	Baseline (before supplementation)
IIEF-5 score	6 weeks of supplementation
IIEF-5 score	12 weeks of supplementation
IIEF-5 score	18 weeks of supplementation
IIEF-5 score	24 weeks of supplementation
EHS score	Baseline (before supplementation)
EHS score	6 weeks of supplementation
EHS score	12 weeks of supplementation
EHS score	18 weeks of supplementation
EHS score	24 weeks of supplementation
level of PSA	Baseline (before supplementation)
level of PSA	6 weeks of supplementation
level of PSA	12 weeks of supplementation
level of PSA	18 weeks of supplementation
level of PSA	24 weeks of supplementation
Testosterone level	Baseline (before supplementation)
Testosterone level	6 weeks of supplementation
Testosterone level	12 weeks of supplementation
Testosterone level	18 weeks of supplementation
Testosterone level	24 weeks of supplementation
LH level	Baseline (before supplementation)
LH level	6 weeks of supplementation
LH level	12 weeks of supplementation
LH level	18 weeks of supplementation
LH level	24 weeks of supplementation
Level of FSH	Baseline (before supplementation)
Level of FSH	6 weeks of supplementation
Level of FSH	12 weeks of supplementation
Level of FSH	18 weeks of supplementation
Level of FSH	24 weeks of supplementation

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N202303063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No