Tokyo, Dec. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059385) titled 'Exploratory Study on the Anti-Aging Effects of a Test Food' on Dec. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of the test food on biological age, as measured by the Epigenetic Clock, as well as its impact on other aging-related parameters and safety.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will take six capsules of the test food twice daily, in the morning and evening, with water or lukewarm water.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy adults aged 40 to under 70 at the time of consent
(2) Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent
Key exclusion criteria - (1) Regular use (>=3 times/week) of specified health foods, functional foods, or supplements, or inability to discontinue such products even if used less than 3 times/week (e.g., NMN, vitamins A/B/C/D/E, DHA/EPA, sesamin, protein, etc.)
(2) Currently receiving pharmacological treatment at the time of consent (excluding as-needed medications)
(3) Excessive alcohol consumption (average >60g/day per week)
(4) Difficulty with blood sampling
(5) Unable to visit the study site
(6) History or current serious disease of the heart, liver, kidneys, digestive system, etc.
(7) Have received a vaccination within 1 month prior to the start of the study, or have a planned vaccination during the study period
(8) Allergies to medications or foods
(9) Participation in another clinical study of drugs or health foods, within 4 weeks after completion of such a study, or plans to participate in another study after consenting to this one
(10) Blood component or 200 mL whole blood donation within 1 month before study start
(11) 400 mL whole blood donation within 3 months before study start
(12) Total blood drawn within 12 months prior to study start, including planned study draws, exceeds 1200 mL
(13) Determined unsuitable for participation by the principal investigator
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 13 Day
Anticipated trial start date - 2025 Year 12 Month 08 Day
Last follow-up date - 2026 Year 03 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067921
Disclaimer: Curated by HT Syndication.