Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059216) titled 'Effects of Maca Intake on Male Fatigue Resistance and Quality of Life' on Nov. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Sukoyaka-Kobo Inc.
Condition:
Condition - Healthy adult males
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether maca intake improves fatigue and quality of life in men.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Foods containing maca-derived ingredients
Interventions/Control_2 - Placebo food
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - (1) Healthy adult males
(2) Individuals with a BMI below 30 kg/m2
Key exclusion criteria - (1) Individuals currently receiving medication for any medical condition
(2) Individuals consuming foods or health supplements containing the active ingredient of this test food
(3) Individuals with functional erectile dysfunction
(4) Individuals with serious diseases or psychiatric disorders affecting glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system; and individuals with a history of such conditions
(5) Individuals who have shown abnormal clinical laboratory values in recent health checkups and are deemed unsuitable for trial participation
(6) Individuals with currently treated diseases or a history of serious diseases requiring medication
(7) Individuals at risk of developing allergies related to the trial
(8) Individuals deemed unsuitable as subjects based on responses to the lifestyle questionnaire
(9) Individuals participating in other clinical studies at the start of this trial
(10) Individuals deemed unsuitable for trial participation by the Principal Investigator (or Study Director)
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 08 Month 26 Day
Anticipated trial start date - 2025 Year 10 Month 05 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067729
Disclaimer: Curated by HT Syndication.
