Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060213) titled 'Confirmatory study of the effects of food component intake on blood flow
(SWE-2025-02)' on Jan. 9.
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 blood flow
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of test foods 1 and exercise intervention (6 weeks)
Interventions/Control_2 - Consumption of test foods 2 and exercise intervention (6 weeks)
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women aged 20 to 64 years
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) Subjects who are receiving some kind of treatment at the time of obtaining consent to participate in the study.
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 - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 11 Day
Date of IRB - 2025 Year 12 Month 10 Day
Anticipated trial start date - 2026 Year 01 Month 09 Day
Last follow-up date - 2026 Year 04 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068869
Disclaimer: Curated by HT Syndication.