Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056745) titled 'A study to verify the effects of test food intake on saliva secretion volume and quality' on March 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Fujicco Co., Ltd.

Condition: Condition - Healthy Japanese subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of test food intake on saliva secretion volume and quality Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Daily intake of test food for 4 weeks Interventions/Control_2 - Daily intake of placebo food for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1) Healthy males and females aged 20 or more and 64 or less 2) Subjects who can give informed consent to participate in this study Key exclusion criteria - 1) Subjects who are allergic to the test food 2) Subjects who are undergoing medical treatment for diseases related to decreased saliva secretion, such as Sjogren's syndrome and salivary gland disorders 3) Subjects who are undergoing medical treatment that cause dry mouth as a side effect, such as medications for mental disorders or urinary disorders. 4) Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, liver cirrhosis, and diabetes. 5) Subjects who regularly take supplements containing antioxidants 6) Subjects who regularly take Herbal medicines, supplements, food, beverages affecting dry mouth, such as the reduced form of Coenzyme Q10. 7) Subjects who are pregnant or lactating, or intending to become pregnant during the study 8) Subjects who took part in another clinical study within 28 days prior to the start of the present study or who are currently taking part in another clinical study 9) Subjects who are judged as ineligible to participate in this study by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 12 Month 24 Day Date of IRB - 2024 Year 12 Month 24 Day Anticipated trial start date - 2025 Year 01 Month 20 Day Last follow-up date - 2025 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064850

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