None listed
Conditions
Interventions
Oral intake of the test food (1 tablet in a day
4 weeks).
Oral intake of the placebo food (1 tablet in a day
4 weeks).
Sponsors
NISSIN FOODS HOLDINGS CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged 20-64 years at the time of obtaining consent to participate in the study. 2) Individuals who have a feeling of stinging in their teeth when eating or drinking cold or sweet foods. 3) Individuals who are concerned about halitosis. 4) Individuals who brush their teeth less than twice a day. 5) Individuals who have be given sufficient explanation about the purpose and contents of this study, volunteer for voluntary participation with good understanding, and can consent to the study. 6) Individuals who can come to the designated venue for this study and be inspected. 7) Individuals who are approved by the responsible doctor as appropriate to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals with oral diseases that require treatment such as caries or periodontal disease. 3) Individuals with a history of current illness or serious illness such as mental illness, hypertension, diabetes, lipid abnormality, Sjoegren syndrome, or rheumatism. 4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 5) Individuals who are a patient or have a history of or endocrine disease. 6) Individuals who have had a habit of taking antibiotics or drugs for disease treatment in the past month. 7) Individuals currently undergoing dental treatment for periodontal disease, caries, or dry mouth. 8) Individuals with dentures, false teeth, or implants (numbers 6 to 8 are acceptable for both upper and lower jaws). 9) Individuals who have had plaque and tartar removed at a dental clinic within the past six months. 10) Individuals who have the habit of using interdental brushes, floss, mouthwash, etc. when brushing their teeth. 11) Individuals who are a smoker. 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 13) Individuals who are sensitive to test food or other foods, and medical products. 14) Individuals with possible changes of lifestyle during the test period. 15) Individuals who have a habit of continuously taking vitamins, foods containing lactic acid bacteria and bifidobacteria, foods with functional claims, health foods, and supplements, or who plan to take them during the test period. 16) Individuals who are pregnant, lactating, or who may become pregnant during the test period. 17) Individuals who participated in other clinical studies in the past 3 months. 18) Individuals who are or whose family is engaged in a company that develops, manufactures, or sells foods with health and functional claims and cosmetics. 19) Individuals judged inappropriate for the study by the responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Evaluation indexes related to the oral environment (Screening, Week 0, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary outcome 1) Evaluation items related to halitosis (Week 0, Week 4) 2) Visual Analogue Scale (Screening, Week 0, Week 4) * Safety indexes 1) Doctor's questions (Screening, Week 0, Week 4) 2) Side effects and adverse events (Week 4) 3) Subject's diary (From the first day of intake of a test material to the last day of the test.) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed