Assessment of health foods made from sea cucumbers

JRCT ID: jRCTs021230060

Registered date:21/02/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Oral candidiasis
Oral mucositis

• Date of first enrollment: 21/02/2024
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Test food A Sea cucumber jelly Contains approximately 4g of sea cucumber processed meat and extract.
Test food B saponin extract added jelly A material obtained by desalting and removing water soluble impurities such as proteins from Manamako using a desorption resin for food processing was added to the jelly instead of the processed mana mako meat extract of test food A.
Test food C control jelly Sea cucumber free jelly made using the same production process as test foods A and B.

Outcome(s)

• Primary Outcome: Differences in the amount of oral candida and streptococcus in oral samples before and after intervention
• Secondary Outcome: Oral cleaning level, evaluation by OHAT-J, denture condition, oral mucosa condition, evaluation of tongue coating amount, oral moisture level

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Persons who can eat food in a healthy manner through the oral cavity
2) A person who has obtained consent from the person concerned or from a representative legal guardian
3) Persons who are 65 years of age or older at the time of obtaining consent

Exclude criteria

1) Persons judged to be unsuitable for research participation, such as facility staff
2) Those who are judged to be unable to participate due to poor physical condition etc. on the day of the survey

Related Information

• Primary Sponsor: Sato Toshiro
• Secondary Sponsor: Yano Akira