None listed
Conditions
Interventions
Daily intake of test food for 4 weeks.
Daily intake of control food for 4 weeks.
Sponsors
Suntory Wellness Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake. (2) Those who can visit the designated facility on the scheduled visit date. (3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Exclusion criteria
Exclusion criteria: (1) Those with systolic blood pressure less than 90 mmHg. (2) Women who wish to become pregnant, are/might be pregnant or lactating during the study. (3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake. (4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake. (5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake. (6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (8) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (9) Those who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to test food e) having a history of cancer or tuberculosis f) positive or false-positive by infectious disease test (10) Those who are receiving any treatment at the time of screening. (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods. (12) Those who smoke an average of 21 or more cigarettes in a day. (13) Those who drink an average of more than 60 g of pure alcohol in a day. (14) Those who have an extremely irregular eating habit. (15) Shift workers or late-night workers. (16) Others who are judged inappropriate for participant by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events Laboratory data, Vital sign | — |
Countries
Japan
Contacts
Public ContactMisaki Onozato
Suntory Holdings Limited Research Strategy Planning Department
Outcome results
None listed