Healthy adults
Conditions
Interventions
Take one tablet of the test food per day for 4 weeks
One tablet of control food per day for 4 weeks
Sponsors
Tokai Gakuen University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese women who are between 18 and 60 years of age at the time of consent. (2) Patients who are not receiving any treatment, whether seasonal, chronic, or sudden, by means of drugs, therapy, or treatment. (3) Participants who fully understand the content of the clinical research and agree in writing of their own free will to participate in this clinical research. (4) Patients whose body temperature is between 35.5 and 37.0. (5) Patients who are able to prohibit binge eating and drinking based on three meals a day during the period of this clinical research. (6) Patients who are able to use appropriate contraception during the period of this clinical research. (7) Patients who are able to understand and comply with the administrative rules during this clinical research period.
Exclusion criteria
Exclusion criteria: (1) Persons with diseases of the gastrointestinal tract, liver, kidney, heart, and circulatory system that affect absorption, distribution, metabolism, and excretion of the test food. (2) Patients with a history of major surgery on the gastrointestinal tract site such as gastrectomy, gastrointestinal suture, or intestinal resection (excluding polypectomy and appendectomy) (3) Those with a history of cerebrovascular disease (4) Those with hypersensitivity or specific constitution such as food allergy related to the test food (5) Patients suspected of alcohol or drug dependence (6) Patients who have participated in other clinical trials or clinical research within the past 84 days from the date of consent (7) Donated 400mL blood within the past 84 days, 200mL blood within the past 28 days, or donated blood components (plasma and platelet components) within the past 14 days from the date of consent. (8) Those who are lactating or pregnant. (9) Those who are engaged in night shift.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Allergy Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight and body fat changes, bowel movement questionnaire | — |
Countries
Japan
Contacts
Public ContactAtsuhisa Nishimura
ICHIBIKI Co., LTD. Research Laboratory
Outcome results
None listed