None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age between 18 and 65 years old at the time of obtaining consent to participate in the study. 2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
Exclusion criteria
Exclusion criteria: Individuals 1)currently undergoing drug treatment for any disease. 2)with a history or current history of serious illnesses such as malignancy, respiratory disease, liver, kidney, heart, lung, gastrointestinal, blood, endocrine, metabolic, drug dependence, alcohol dependence, mental disorders, etc. 3)with a history or current history of drug or food allergies. 4)with serious anemia. 5)who are pregnant, intend to become pregnant during the study period, or are breastfeeding. 6)Excessive smokers (average of more than 21 cigarettes/day). 7)who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 8)who cannot discontinue functional foods, foods for specified health uses, foods with nutrient function claims, supplements or foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, lactoferrin, etc. during the study period. 9)who may require medication treatment due to hay fever or other allergic symptoms during the study period (excluding eye and nose drops). 10)Starting from the date of obtaining the consent document, women who had a blood draw of 400 mL or more within 16 weeks, men who had a blood draw of 400 mL or more within 12 weeks, or who had a blood draw of 200 mL or more within 4 weeks. 11)vaccinated within 4 weeks prior to the date of obtaining the consent document. 12)who work late night or shift work, physical labor, or have irregular lifestyle habits. Also, who may change their lifestyle during the examination period. 13)who are participating, or intend to participate, in research involving the ingestion of other foods or the use of pharmaceuticals, or the application of cosmetics and pharmaceuticals, or who have participated in other clinical research within 4 weeks prior to obtaining consent. 14)who are judged by the investigator to be unsuitable for the study based on the results of the subject's background, physical examination, interview, blood pressure and pulse rate, and clinical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (Pre-intake, 2 weeks and 4 weeks after intake, and 2 weeks after the end of intake of test food) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) 2)Physical xamination 3)Clinical examination 4)Doctor's questions 5)Exploratory study | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed