None listed
Conditions
Interventions
Oral ingestion of a test food (3 packets in a day
4 weeks).
Oral ingestion of a placebo food (3 packets in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy men and women aged 20 to 64 at the time of obtaining consent to participate in the study. 2) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to consent, have voluntarily applied to participate after fully understanding the study, and are able to provide written consent to participate in the study. 3) Individuals who are able to visit the facility on the designated examination date and undergo the examination. 4) Individuals deemed suitable for participation in the study by the principal investigator.
Exclusion criteria
Exclusion criteria: Individuals 1) currently suffering from any medical condition and undergoing drug treatment. 2) with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of severe cases of these conditions. 3) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system. 4) who regularly take medication or have a history of taking medication for the treatment of medical conditions within the past month (excluding occasional use for conditions such as headaches, menstrual cramps, or colds) . 5) with a BMI of 30 kg/m2 or higher. 6) who may experience allergic reactions to ingredients contained in the test food, or who may experience allergic reactions to other foods or medications. 7) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month, or 400 mL within the past three months. 8) whose daily alcohol consumption exceeds an average of 40 g of alcohol per day for men and 20 g of alcohol per day for women, calculated on a weekly basis. 9) whose daily routines may change during the study period (e.g., night shifts, extended travel) . 10) who currently consume, or have consumed within the past three months, health functional foods, health foods, or supplements on a regular basis, or who plan to consume such products during the study period. 11) who are pregnant, breastfeeding, or may become pregnant, or who intend to become pregnant during the study period. 12) currently participating in another clinical trial, or those who have participated in another clinical trial within the past three months. 13) whose family members or themselves are employed by a company that develops, manufactures, or sells health foods, functional foods, or cosmetics. 14) Any other individuals deemed ineligible for this trial by the principal investigator.
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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Trends and Changes in Physical Examination Findings -Blood pressure/pulse rate -Weight/body fat percentage/BMI 2) Trends and Changes in Laboratory Test Results -Hematological tests -Biochemical blood tests -General urinalysis 3) Medical consultation 4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed