Tokyo, Aug. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058758) titled 'Exploratory Study on the Geroprotective Effects of Combined Interventions' on Aug. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - AutoPhagyGO Inc.
Condition:
Condition - Healthy elderly
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - To evaluate the overall anti-aging effects of multiple interventions targeting diet, physical activity, and sleep on cognitive function, muscle strength, and immune function, and to assess the burden on participants in terms of tolerability and feasibility.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Awa Bancha Autophagy 100 (APGO)
Autophagy Habit NMN25000+ (Mikakuto)
Fine Autophagy ReCell (Fine)
Eating time limit (within 12 hours)
Sleep (7 hours or more)
Exercise (5 days a week, at least one day at the gym)
Interventions/Control_2 - No interventions
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy adults (male and female) aged 50 to 80 years at the time of consent (without any disease related to the study)
(2) Individuals who have received a full explanation of the purpose and content of the study, fully understood the purpose, and voluntarily volunteered to participate and provided written consent to participate in the study.
Key exclusion criteria - (1) Individuals who regularly take specified health foods, functional foods, or health foods (including supplements) at least three times a week and are unable to discontinue use of these foods at the time of consent acquisition (e.g., vitamins A, B, C, D, E, DHA/EPA, sesamin, protein, etc.) that may affect the study.
(2) Individuals currently undergoing medication at the time of consent acquisition (however, illnesses unrelated to the measurement are acceptable).
(3) Individuals who drink a lot of alcohol.
(4) Individuals for whom blood sampling is difficult.
(5) Individuals who have difficulty commuting to the examination site.
(6) Individuals who are unable to perform the exercises required for the examination due to joint or muscular issues.
(7) Individuals with a history or current medical history of serious heart, liver, kidney, or digestive diseases.
(8) Individuals with drug or food allergies.
(9) Individuals who are currently participating in a clinical study of another drug or health food, or who have completed the study within four weeks of the study's completion,
or who plan to participate in another clinical study after agreeing to participate in the current study.
(10) Individuals who have donated blood components or 200 mL of whole blood within one month prior to the start of the study.
(11) Individuals who have donated 400 mL of whole blood within three months prior to the start of the study.
(12) Individuals whose total planned blood collection volume for the study exceeds 1,200 mL when added to the volume of blood collected within 12 months prior to the start of the study.
(13) Individuals who are deemed inappropriate for participation in this study by the principal investigator or co-investigators.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 26 Day
Date of IRB - 2025 Year 07 Month 26 Day
Anticipated trial start date - 2025 Year 07 Month 27 Day
Last follow-up date - 2025 Year 12 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067187
Disclaimer: Curated by HT Syndication.
