Tokyo, July 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062109) titled 'An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Nagoya University of Arts and Sciences
Condition:
Condition - Healthy elderly
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of 8-week intake of a prebiotic sweetener (containing inulin, kestose, and agaro-oligosaccharide) on dietary habits, gut microbiota (diversity, abundance of beneficial bacteria), and frailty-related factors (physical function, cognitive function, and nutritional status) in healthy elderly individuals residing in N City.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Daily intake of prebiotic sweetener (syrup containing inulin, kestose, and agaro-oligosaccharide) using a dedicated spoon (approx. 17g/day: containing 3.4g kestose, 8.5g inulin, and 17mg agaro-oligosaccharide) at breakfast for 8 weeks.
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Healthy residents of N City aged 65 or older will be recruited through the city's public relations newsletter. Eligible participants include both men and women who have no physician-diagnosed gastrointestinal diseases and have provided written informed consent.
Key exclusion criteria - -
Target Size - 50
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 08 Month 19 Day
Date of IRB - 2024 Year 09 Month 23 Day
Anticipated trial start date - 2024 Year 10 Month 22 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=R000071067
Disclaimer: Curated by HT Syndication.