Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060130) titled 'A study to confirm the effects of continued intake of test food consumption on oral function in children' on June 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Morinaga & Co., Ltd.

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine the changes in oral function in children due to the continued intake of the test food. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of the test food for 4 weeks

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - Child (1) Healthy male and female aged 6 to 9 years at the time point of acquiring the informed consent. (2) Those who do not currently have dental care affecting their occlusion. (3) Those who do not currently have braces. (4) Those whose first molars have erupted. (5) Those who are able to eat the test food twice daily. (6) Those with a body weight of 16.0 kg or more at the time informed consent is obtained. (7) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents. (8) Those who are judged by the investigator that they have no problem participating in the study.

Parent (9) Parents of healthy male and female aged 6 to 9 years at the time point of acquiring the informed consent. (10) Those who can cooperate with diary and questionnaire (11) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents. Key exclusion criteria - (1) Those who have a history of medication, hospitalization, or surgery within a year. (2) Those who have or suspected infectious disease such as COVID-19, or who are in close contact with such a disease on study entry. (3) Those who are currently on any medical treatments, or who are planning some kind of treatments during the study period. (4) Those who cannot eat chewing soft candy. (5) Those who have allergy in medicine, foods. (Especially gelatin). (6) Those who are unable to come to the venue on the day of the examination. (7) Those who have participated in other clinical trials within 3 months prior to the date of consent, are currently participating in a clinical trial of another drug or health food, or are scheduled to participate in another clinical trial after consent to participate in this trial. (8) Those who judged by the principal investigator to be unsuitable for participation in the study. Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 18 Day Date of IRB - 2025 Year 09 Month 18 Day Anticipated trial start date - 2026 Year 01 Month 17 Day Last follow-up date - 2026 Year 03 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068595

Disclaimer: Curated by HT Syndication.