Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059997) titled 'A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study-' on Dec. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - APO PLUS STATION CO., LTD.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effects of consuming test food on hormonal and related paraments over a 12-week period. In addition, the long-term safety of the test food will be assessed during the same time frame.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Daily consumption of the test food over 12 weeks.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male
Key inclusion criteria - (1) Healthy Japanese males aged 40 years old or older but under 65 at the time of consent.
(2) Individuals who report subjective symptoms such as fatigue, lethargy, lack of energy, or decreased libido.
(3) Individuals who have results from a health examination conducted within the past year and show no abnormalities requiring treatment.
(4) Individuals who have received sufficient explanation about the study and have signed the informed consent form prior to the study initiation.
Key exclusion criteria - (1) Individuals who are currently undergoing treatment for, or have a history of, malignant tumors, heart failure, or myocardial infarction.
(2) Individuals currently receiving treatment for, or with a history of, the following conditions:
[1] Arrhythmia, liver dysfunction, renal impairment, cerebrovascular disease, thyroid disorders, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses.
[2] Conditions requiring hormone therapy.
(3) Individuals currently undergoing treatment for, or with a history of, drug or alcohol dependence.
(4) Individuals diagnosed with male infertility.
(5) Individuals with mental disorders, depressive symptoms, or currently receiving treatment for such conditions.
(6) Individuals with food allergies or those who may have allergic reaction to test food.
(7) Individuals who regularly use prescription drugs or quasi-drugs that may affect the study outcomes and are unable to discontinue their use during the study period.
(8) Individuals who regularly consume health foods that may affect the study outcomes and are unable to discontinue their use during the study period.
(9) Individuals who consume excessive amounts of alcohol.
(10) Individuals with heavy smoking habits.
(11) Individuals unable to abstain from alcohol and smoking from the day before each visit until the end of the examination.
(12) Individuals who may be unable to maintain their usual lifestyle.
(13) Individuals with extremely irregular lifestyle habits, such as night shift workers.
(14) Individuals planning to travel abroad during the study period.
(15) Individuals who participated in another clinical trial within one month prior to the date of consent, or plan to participate in another clinical trial during the study period.
(16) Individuals deemed inappropriate for participation by the principal investigator.
Target Size - 13
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 12 Month 03 Day
Anticipated trial start date - 2025 Year 12 Month 07 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068567
Disclaimer: Curated by HT Syndication.
