Healthy individuals
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy men and women whose age at the time of obtaining consent is between 20 and 70 2) Those who have had stomach upset after meal for the past month 3) Those who can visit the medical facility where the test is conducted 4) Those who were not judged to lack consent by the investigator
Exclusion criteria
Exclusion criteria: 1) Serious liver disorder, kidney / heart disease, organ disorder, diabetes, food allergic disease, gastrointestinal disorder, anxiety disorder, depression, sleep disorder, other serious disease, or person with the history 2) Those with a history of surgery for organic diseases (peptic ulcer, gastritis, reflux esophagitis, etc.) and gastrointestinal diseases 3) Person with stomach pain as chief complaint 4) Those who received H.pylori eradication treatment within 6 months 5) Persons with a history of drug dependence or alcohol dependence 6) Persons who are allergic to drugs and food, or who are hypersensitive to the test food (eczema, nausea, diarrhea, etc.) 7) Persons with a history of mental disorders (such as depression) 8) Those who use pharmaceuticals that may affect this study, foods for specified health use, foods with functional claims, supplements, and health foods, and cannot be stopped during the study period 9) Persons who cannot stop taking specified health foods, foods with functional claims, supplements and health foods during the test period 10) Those who continue to use pharmaceuticals (OTC, internal medicines including prescription drugs) 11) Person who drinks over 1,000 mL (40 g in alcohol equivalent) per day of normal beer (5%) 12) Those who are taking warfarin 13) Pregnant and breastfeeding, and those who plan to do so 14) Person who donated blood components or 200 mL of whole blood from the month before the start of the test to the start of the test, or who donated 400 mL or more within 3 months 15) Those who have participated in other clinical trials within one month from the time of obtaining consent, or who are scheduled to participate in other clinical trials 16) Other persons who are deemed inappropriate by the study investigator to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (Fullness, Stomach feeling, appetite, general fatigue, sleepiness, defecation desire) | — |
Countries
Japan
Contacts
APO PLUS STATION CO., LTD. CRO Department Food Test Division