Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063026) titled 'Does Fructan Induced Modulation of the Gut Microbiota Improve Body Composition in Middle Aged and Older Adults?' on Sept. 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Nagoya University of Arts and Sciences
Condition:
Condition - Middle-Aged and Older Adults
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - In middle-aged and older adults, we will analyze the gut microbiota and assess health-related outcomes, including body composition, physical function, depressive symptoms, and sleep status, to evaluate the effects of consuming a sweetener containing the prebiotics 1-kestose and inulin.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the prebiotic group will consume 17 g of an oligosaccharide-containing sweetener (3.4 g of 1-kestose and 8.5 g of inulin; 33 kcal) once daily with breakfast. The intervention will continue for 8 weeks.
All participants will also be instructed to perform a prescribed 15-minute exercise program, consisting of stretching,calisthenics, and aerobic exercises every day.
Interventions/Control_2 - Participants in the placebo group will consume 10 g of maltose (33 kcal) once daily with breakfast. The intervention will continue for 8 weeks.All participants will also be instructed to perform a prescribed 15-minute exercise program, consisting of stretching,calisthenics, and aerobic exercises every day.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - Participants without a physician-diagnosed gastrointestinal disease who provide written informed consent will be included.
Key exclusion criteria - Individuals with a physician-diagnosed gastrointestinal disease or those currently taking antibiotics will be excluded.
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 26 Day
Date of IRB - 2026 Year 08 Month 27 Day
Anticipated trial start date - 2026 Year 08 Month 26 Day
Last follow-up date - 2026 Year 12 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072146
Disclaimer: Curated by HT Syndication.