None listed
Conditions
Interventions
4 weeks).
Oral intake of the placebo food (1 packet in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 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: 1) Individuals currently suffering from any chronic disease and receiving drug treatment. 2) Individuals with a history of serious illnesses. 3) Individuals who are unable to participate in the study due to liver, kidney, or heart disease, respiratory disorders, endocrine disorders, metabolic disorders, neurological disorders, impaired consciousness, diabetes, or other illnesses. 4) Individuals with a history of gastrointestinal diseases or gastrointestinal surgery that affect digestion and absorption (excluding appendicitis) . 5) Individuals with a current or past history of drug or food allergies. 6) Individuals with a systolic blood pressure of less than 90 mmHg. 7) Individuals with severe anemia. 8) Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL in the past three months. 9) Individuals who have previously experienced ill health or worsening physical conditions after blood collection. 10) Individuals who regularly consume foods for specified health uses, foods with functional claims, or health foods. 11) Individuals who are pregnant, lactating, or may become pregnant. 12) Individuals who are heavy smokers (average smoking of 21 or more cigarettes per day). 13) Individuals whose daily alcohol intake exceeds 60 g/day of pure alcohol per week. 14) Individuals with a history or current medical history of drug or alcohol dependence. 15) Individuals who may change their lifestyle during the study period (night shifts, long-term travel, etc.). 16) Individuals currently participating in a study involving the intake of other foods or medications, or the application of cosmetics or medications, within the last four weeks of completing a study, or individuals who intend to participate. 17) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Adverse events: number of cases and incidence rate of adverse events (incidence rate: number of cases/number of cases analyzed) 2)Side effects: number of cases and incidence rate of side effects (incidence rate: number of cases/number of cases analyzed) 3)Physical examination (Body weight / Body fat percentage / Body mass index, Blood pressure / Pulse rate) 4)Clinical examination (Hematological test, Biochemistry test, Urinalysis) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed