Maca Extract in Sexual Dysfunction Male

October 10, 2023 updated by: Taipei Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
IIEF-5 score
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
IIEF-5 score
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
IIEF-5 score
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
IIEF-5 score
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
IIEF-5 score
Time Frame: 24 weeks of supplementation
24 weeks of supplementation
EHS score
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
EHS score
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
EHS score
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
EHS score
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
EHS score
Time Frame: 24 weeks of supplementation
24 weeks of supplementation
level of PSA
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
level of PSA
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
level of PSA
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
level of PSA
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
level of PSA
Time Frame: 24 weeks of supplementation
24 weeks of supplementation
Testosterone level
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
Testosterone level
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
Testosterone level
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
Testosterone level
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
Testosterone level
Time Frame: 24 weeks of supplementation
24 weeks of supplementation
LH level
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
LH level
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
LH level
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
LH level
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
LH level
Time Frame: 24 weeks of supplementation
24 weeks of supplementation
Level of FSH
Time Frame: Baseline (before supplementation)
Baseline (before supplementation)
Level of FSH
Time Frame: 6 weeks of supplementation
6 weeks of supplementation
Level of FSH
Time Frame: 12 weeks of supplementation
12 weeks of supplementation
Level of FSH
Time Frame: 18 weeks of supplementation
18 weeks of supplementation
Level of FSH
Time Frame: 24 weeks of supplementation
24 weeks of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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