Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060815) titled 'Trial of the efficacy of multi-factorial lifestyle intervention on non-cognitive function in older people
(SWE-2025-04-HBPUFA)' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Suntory Wellness Limited
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of multi-factorial lifestyle intervention with food ingredients on non-cognitive function.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Daily intake of test food and lifestyle intervention for 12 weeks
Interventions/Control_2 - aily intake of control food for 12 weeks (without lifestyle intervention)
Eligibility:
Age-lower limit - 55
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Women and men aged 55 to 74 years.
2) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria - 1) Person who has difficulty in implementation of non-cognitive function test and neuropsychological test.
2) Person whose score of neuropsychological test was lower than a certain score.
3) Person whose score of neuropsychological test was higher than a certain score.
4) Use of product affecting the data of this study, such as medicine and food for specified health use.
5) Presence of previous and present serious disease such as neurological disorder, psychiatric disorder, liver disorder, kidney disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
6) Investigator's judgment for other reason.
Target Size - 134
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 12 Day
Anticipated trial start date - 2026 Year 08 Month 18 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=R000069584
Disclaimer: Curated by HT Syndication.