Healthy adult
Conditions
Interventions
Daily intake of test food A once a day for 12 consecutive weeks
Daily intake of test food B once a day for 12 consecutive weeks
Daily intake of test food C once a day for 12 consecutive weeks
Non-inte
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 65 years of age (2) Subjects whose lunch consists only of the test food and who have no difficulty consuming the entire portion (3) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: Subjects (1)whose blood pressure in the examination room during screening is at or above the level classified as high blood pressure (2)who do not have the habit of eating lunch or whose eating habits are extremely irregular (3)who cannot stop consuming foods and beverages related to the study from the time of the screening (4)with a medical history of diseases requiring dietary and exercise therapy under a doctor's supervision (5)who regularly take health supplements and cannot stop taking them during the study period (6)who regularly use pharmaceutical drugs or quasi-drugs and cannot restrict their intake during the research period (7)currently receiving medical treatment for gastrointestinal diseases that could affect the research, or those with a history of gastrointestinal surgery (8)suspected of having, currently being treated for, or with a history of disorders related to bowel movements, sleep, stress, or fatigue (9)who have shown abnormalities in clinical test values or cardiopulmonary function and are deemed unsuitable for participation in the study (10)who may be at risk of developing allergies in relation to the research (11)who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment (12)who work in shifts, night shifts, or have irregular daily schedules (13)Heavy drinkers and smoker (14)who have participated in other clinical studies from within one month before the date of consent until four weeks after the end of the trial (15)who plan to become pregnant or breastfeed during the study period (16)expected to experience significant changes in their living environment during the research period (17)whose blood donation volume before the start of the study exceeds the regulations (18)who are aware of imbalances in nutritional intake (19)deemed inappropriate as subjects by the responsible investigator (20)using implanted medical electrical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat percentage, waist circumference, abdominal visceral fat area, gut short-chain fatty acids, gut putrefactive products, gut microbiota, physical measurements, physiological tests, clinical tests, nutrient intake (sodium, potassium, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| IPAQ short, OSA-MA, STAI, brief job stress questionnaire, POMS2, VAS, Chalder fatigue scale, MAIA, water intake, bowel movements | — |
Countries
Japan
Contacts
Public ContactShingo Yamamichi
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed