Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060374) titled 'Effects of Continuous Food Intake on Subjective Symptoms Related to Physical Condition' on Jan. 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Lotte Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Effects of Continuous Food Intake on Subjective Symptoms Related to Physical Condition
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Food intake
Interventions/Control_2 - No intake
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Subjects who enjoy eating the test food
(2) Subjects who have received a thorough explanation of the trial's purpose and content, possess the capacity to consent, have fully understood the information, voluntarily volunteered to participate, and have provided written consent to participate in this trial
Key exclusion criteria - (1) Subjects experiencing symptoms that may affect their ability to consume the test food
(2) Subjects currently undergoing dental treatment, including orthodontic treatment (excluding routine cleanings)
(3) Subjects at risk of developing allergies related to the trial
(4) Pregnant or breastfeeding women
(5) Subjects deemed unsuitable for participation in this trial by the principal investigator
(6) Other subjects deemed unsuitable for participation in this trial by the principal investigator
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 22 Day
Date of IRB - 2026 Year 01 Month 15 Day
Anticipated trial start date - 2026 Year 01 Month 19 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=R000069063
Disclaimer: Curated by HT Syndication.