Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058901) titled 'Effects of a Multimodal Lifestyle Intervention on Physical, Immune, and Cognitive Functions: A Prospective Interventional Study in Adults' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Adults who are independent in activities of daily living
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to conduct an 8-week lifestyle intervention program for adults (both men and women, aged 50 to 80 years) who are independent in activities of daily living. The program will combine dietary guidance, fasting, exercise, supplementation, yoga, cognitive training, and thermal therapy. The objective is to comprehensively evaluate its efficacy and safety. Specifically, efficacy will be assessed in terms of physical function, cognitive function, immune function, and aging-related biomarkers.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - An 8-week lifestyle modification intervention program, consisting of dietary guidance, fasting, exercise, supplementation, yoga, cognitive training, and thermal therapy, will be provided to individuals who voluntarily wish to participate. By assessing each outcome measure before and after the program, changes in muscle strength, cognitive function, immune function, and biological aging markers will be analyzed.
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Male and Female
Key inclusion criteria - Men and women who are independent in activities of daily living will be eligible.
Key exclusion criteria - systemic infection; acute or chronic viral hepatitis; poorly controlled diabetes mellitus; severe renal or hepatic dysfunction; serious cardiovascular or cerebrovascular disease within the past 6 months; presence of a pacemaker; severe gastrointestinal disease or gastrointestinal surgery within the past 12 months; active malignancy within the past 5 years; current pregnancy or planned pregnancy; and breastfeeding.
Target Size - 14
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 08 Month 08 Day
Date of IRB - 2025 Year 08 Month 08 Day
Anticipated trial start date - 2025 Year 08 Month 09 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067349
Disclaimer: Curated by HT Syndication.