Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058334) titled 'Confirmatory study of the effects of food component intake on QOL (Quality of Life)(SWE-2025-01)' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Suntory Wellness Limited
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the impact of food intake on QOL (Quality of Life)
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of test foods (4 weeks)
Interventions/Control_2 - Consumption of control foods(4 weeks)
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women aged 40 to 64 years old
2) Subjects who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria - 1) With previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus.
2) Subjects who keep irregular hours such as shift work.
3) Heavy drinker of alcohol.
4) Use of products affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
5) Investigator's judgment for other reason.
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 06 Month 27 Day
Anticipated trial start date - 2025 Year 10 Month 11 Day
Last follow-up date - 2025 Year 11 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066688
Disclaimer: Curated by HT Syndication.
