Healthy population
Conditions
Interventions
Plant-derived extracts
Placebo
Sponsors
other
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Japanese males between the ages of 20 and 60 years at the time of consent (2) BMI between 18.5 kg/m2 and 25.0 kg/m2 at screening (3) Systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg at screening (4) Those who agree to participate in the study and are able to sign and date the consent form themselves
Exclusion criteria
Exclusion criteria: (1) Participants with a history of serious medical history or surgical resection of the digestive tract (excluding appendicectomy and endoscopic polypectomy) (2) Participants with diseases affecting excretion, digestion and absorption, or those who are aware of various symptoms of indigestion, constipation, diarrhea, etc. on a daily basis (3) Participants with a history of treatment for pre-existing abnormalities in renal function, liver function, blood pressure level, glucose or lipid metabolism (4) Participants who are taking oral drugs or supplements on a regular basis (5) Heavy alcohol drinkers (>60g of pure alcohol/day) and excessive smokers (>20 cigarettes/day) (including those who are unable to quit smoking during the clinic visit time frame or those who are unable to maintain mental and physical health by quitting smoking) (6) Participants who are participating or will participate in an interventional trial involving the intake of other foods or drugs, or the application of cosmetics or quasi-drugs. (7) Participants who work late at night (22:00-5:00) or work overtime for a long period of time. (8) Participants who have donated 400 mL of blood within 6 months prior to this study. (9) Participants who have food allergies or dislike foods, including the test food and the standardized meal. (10) Participants who may not be able to consume ingredients whose origin is not specified in the test food due to religious or other reasons. (11) Participants who are otherwise judged by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in urinary sodium | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood sodium | — |
Countries
Japan
Contacts
Public Contactmasaya tsubokawa
FANCL Research Institute clinical trial group
Outcome results
None listed