Healthy volunteers
Conditions
Interventions
Ingestion of the test food for 4 consecutive weeks
Ingestion of placebo (control food) for 4 consecutive weeks
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 30 to under 65 at the time of informed consent 2) Individuals experiencing gastric discomfort, such as early satiety or postprandial fullness while eating 3) Individuals who scored 3 points on any of items 7-9 of the Izumo Scale during screening and observation periods, and whose total score for these items was 4 points or higher 4) Individuals who received a full explanation of the study and signed the informed consent form before study initiation 5) Individuals able to compete assessments in a remote environment (e.g., via web-based questionnaires)
Exclusion criteria
Exclusion criteria: 1) Individuals with organic gastrointestinal diseases (peptic ulcers, gastritis, reflux esophagitis) 2) Individuals currently receiving treatment for functional dyspepsia 3) Individuals with a current or medical history of irritable bowel syndrome 4) Individuals currently presenting with heartburn or epigastric pain as their main complaint 5) Individuals who visited a clinic for gastric symptoms within the past 6 months and did not respond to medications related to those symptoms 6) Individuals who have regularly taken medications for gastric symptoms within the past year 7) Individuals who have undergone Helicobacter pylori eradication therapy within the past 6 months, or who are H. pylori antibody-positive 8) Individuals with a history of gastrointestinal surgery 9) Individuals with pancreatic or biliary diseases, liver disease, kidney disease, severe heart disease, malignant tumors, or inborn errors of amino acid metabolism 10) Individuals with a history of treatment for anxiety disorders, depression, or sleep disorders 11) Individuals with a current or medical history of drug or alcohol dependence 12) Individuals who consume excessive amounts of alcohol 13) Individuals with highly irregular alcohol consumption habits 14) Individuals with drugs or, food allergies or those who may react to the provided food in this trial 15) Individuals with some diseases undergoing outpatient treatment 16) Individuals who regularly skip at least one meal per day 17) Individuals who Currently smoke or have smoked within the past month 18) Individuals with irregular lifestyles such as night and day shift work 19) Individuals who may be unable to maintain their daily lifestyle 20) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period 21) Individuals who joined another clinical trial within one month before consent or plan to join one during the study 22) Individuals deemed ineligible by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Izumo Scale Indigestion Symptom Score (sum of questions 7-9) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Izumo Scale individual item scores (questions 1-15), heartburn symptom score (sum of items 1-3), gastralgia symptom score (sum of items 4-6), Functional Dyspepsia (FD) symptom score (sum of items 4-9), constipation symptom score (sum of items 10-12), diarrhea symptom score (sum of items 13-15) 2) Visual Analog Scale (VAS) for gastric discomfort 3) Visual Analog Scale (VAS) for appetite 4) SF-36v2 Japanese Version (acute form) 5) Daily Log (test food intake, portion sizes for each meal, intake of fats and stimulants) | — |
Countries
Japan
Contacts
Public ContactMisaki Sakata
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed