Evaluation Study on the Effects of Anti-Aging Ingredients Intake in Enhancing Salivary Secretion

UMIN ID: UMIN000052628

Registered date:27/10/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Male/female adults
• Date of first enrollment: 2023/10/30
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption one tablet of the test food
Consumption one tablet of the placebo food

Outcome(s)

• Primary Outcome: Changes in resting salivary volume
• Secondary Outcome: VAS for mouth dryness

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who regularly consume Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health foods (including supplements) more than three times a week, which may potentially affect the study, and are unable to discontinue from the time of consent acquisition. 2. Subjects who are taking the following medications more than two days a week and cannot restrict their use during the study period, as they may potentially affect the study: Antihistamines Cold medicines (e.g., Contac 600) Medicines that suppress stomach acid: H2 blockers (e.g., Gaster 10), proton pump inhibitors (e.g., Takepron, Takecab) Hypertension drugs: Calcium antagonists (e.g., Adalat) Medications for frequent urination (e.g., BUP-4) Antipsychotic drugs, anti-anxiety drugs, sleep medications Other medications that may cause oral dryness 3. Subjects who, at the time of consent acquisition, have plans for oral treatments such as dental treatments or oral cleanings during the study period. 4. Subjects who have been diagnosed with dry mouth or Sjogren's syndrome. 5. Subjects who are in the habit of smoking, or have been in the habit of smoking within the past year. 6. Subjects with excessive alcohol intake. 7. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 8. Subjects with severe or progressive pre-existing conditions or symptoms. 9. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 10. Subjects having some kind of drug and/or food allergy. 11. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Meiji Holdings Co., Ltd.