Tokyo, Aug. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062359) titled 'Food Intake Training for Working-Age Adults' on Aug. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-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 Food Intake Training on Physical and Oral Health in Working-Age Adults
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test food
Interventions/Control_2 - No intake
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Subjects giving written informed consent
(2) Individuals with no oral health issues regarding the consumption of test foods
(3) Individuals capable of participating in the training
Key exclusion criteria - (1) Participants who withdrew their consent to participate in the trial for reasons unrelated to the trial itself, but due to their own personal circumstances
(2) Participants who experienced a serious adverse event, and for whom the principal investigator or co-investigator determined that the trial should be discontinued
(3) Participants for whom the principal investigator or co-investigator determined that continuing the trial was unfeasible based on subjective or objective symptoms
(4) Participants for whom it was determined after the start of the trial that they did not meet the eligibility criteria
(5) Participants who do not follow the instructions of the principal investigator, sub-investigator, or other designated personnel
(6) Other participants for whom the principal investigator or sub-investigator determined that trial participation should be discontinued
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 18 Day
Date of IRB - 2026 Year 07 Month 09 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071346
Disclaimer: Curated by HT Syndication.