Healthy volunteers
Conditions
Interventions
The trial food will be consumed once, followed by a washout period, then the control food will be consumed once.
After consuming the control food once, a washout period will follow, and the test food
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 20 to under 60 at the time of informed consent. 2) Participants who with a BMI >=18.5 kg/m2 and <25kg/m2. 3) Participants who received a full explanation of the study and signed the informed consent form before study initiation.
Exclusion criteria
Exclusion criteria: 1) Participants with a history of serious illness or gastrointestinal surgery. 2) Participants with diseases affecting gastric emptying or digestion/absorption, or who regularly experience symptoms such as indigestion, constipation, or diarrhea. 3) Participants with abnormal kidney or liver function, blood pressure, or glucose/lipid metabolism. 4) Participants who regularly use medications (including Kampo), or quasi-drugs or supplements. 5) Participants who regularly consume health foods (e.g., FOSHU, foods with functional claims) that may affect the study and cannot discontinue them during the study period. 6) Participants who consume excessive amounts of alcohol. 7) Participants who Currently smoke or have smoked within the past year. 8) Participants planning to travel abroad during the study period. 9) Participant with irregular work hours or engaged in shift work. 10) Participants who may be unable to maintain their lifestyle due to dietary restrictions. 11) Participants with food allergies or those who may react to the trial or provided food. 12) Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. 13) Participants who joined another clinical trial within one month before consent or plan to join one during the study. 14) Participants deemed ineligible by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of carotenoid (lutein/zeaxanthin/astaxanthin) concentration in blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood carotenoid concentrations (lutein/ zeaxanthin/ astaxanthin) at each time point and Cmax | — |
Countries
Japan
Contacts
Public ContactShuka Futagami
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed