A study to confirm the effects of test food consumption on oral function and health in children

A study to confirm the effects of test food consumption on oral function and health in children - A study to confirm the effects of test food consumption on oral function and health in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054246

Enrollment

Registered

2024-07-31

Start date

2024-05-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral ingestion of the test food for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Child (1) Healthy male and female aged 6 to 12 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 once daily. (6) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents. (7) Those who are judged by the investigator that they have no problem participating in the study. Parent (8) Parents of healthy male and female aged 6 to 12 years at the time point of acquiring the informed consent. (9) Those who can cooperate with diary and questionnaire (10) Those who have received explanation and understood about this study, and who can consent to the content on the informed consent documents.

Exclusion criteria

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 hospital 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.

Design outcomes

Primary

Measure	Time frame
oral function and health index	—

Countries

Japan

Contacts

Public ContactItaru Aoyama

Morinaga & Co., Ltd. R&D institute

i-aoyama-af@morinaga.co.jp045-571-6140

Outcome results