Verification research of oral environment-improving effects by test-food consumption

UMIN ID: UMIN000050090

Registered date:24/01/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2023/01/24
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingesting a drop of the test food, once a day
Ingesting a drop of the placebo food, once a day

Outcome(s)

• Primary Outcome: Salivary secretion volume (Saxon test)
• Secondary Outcome: 1. Oral bacteria (caries-related bacteria; Total Streptococci, Mutans Streptococci, Lactobacillaceae, and periodontal disease-related bacteria; Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythensis, Treponema denticola, Fusobacterium nucleatum) 2. Questionnaire (Visual Analogue Scale)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Subjects - - (1) who take steadily (over 3 times a week) in affecting health-specific/functional (e.g., reduced coenzyme Q10, L. reuteri)/supplementary/health foods, (2) who have taken affecting medicines (e.g., anti-biotic/fungal/histamine/hypertensive), and have any difficulty in refraining from taking them during this research, (3) who use an oral care product (e.g., mouthwash), except for toothbrush/paste, and have any difficulty in refraining from using them during this research, (4) who have been to the hospital for dental treatment within 3 months prior to the consent, or those who are now under the treatment (including scaling tartar and plaque), (5) with salivary secretion of less than 2 g at pre-test, (6) who have been diagnosed as dry mouth or Sjogren's syndrome, (7) fully realized that their gums are liable to bleed, (8) equipped with full dentures, (9) with smoking (including no smoking less than 1 year), (10) with excessive alcohol intakes, (11) who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases, (12) with pregnancy, possibly one, or lactating, (13) having drug/food allergy, (14) who are now under other clinical studies with medicine or health food, or partook in those within 4 weeks before this research, (15) who donated over 0.2 L of their blood and/or blood components within a month to this research, (16) who donated his whole blood (0.4 L) within the last 3 months to this research, (17) who donated her whole blood (0.4 L) within the last 4 months to this research, (18) who will be collected in total of his blood (1.2 L) within the last 12 months, after adding the blood amounts planning to be sampled in this research, (19) who will be collected in total of her blood (0.8 L) within the last 12 months, after adding the blood amounts planning to be sampled in this research, (20) who have been determined as ineligible for participation, judging from the principal/sub investigator - - .

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: ORYZA OIL & FAT CHEMICAL