Healthy adults
Conditions
Interventions
Placebo beverage (For 12 weeks)
Beverage containing low-plant-derived components (For 12 weeks)
Beverage containing high-plant-derived components (For 12 weeks)
Sponsors
KAGOME CO., LTD.
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults (ages 40 and over, under age 65, except for premenopausal women) 2) Subjects whose FMD is 4% and over. 3) Subjects who receive a sufficient explanation of the purpose and content of this study, have the ability to fully understand and consent it, and have voluntarily apply for participation with written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who have a chronic disease and are undergoing treatment 2) Subjects with a history or current medical history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease, or other metabolic disease 3) Subjects diagnosed with arrhythmia at the screening test 4) Subjects who are judged unsuitable for this study based on the screening test 5) Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption 6) Subjects who have allergies to drugs or foods (especially test foods) 7) Subjects who cannot stop taking a supplement or a supplement/healthy food that may affect vascular endothelial function or blood pressure during the study period 8) Subjects who consume foods containing a large amount of the plant-derived component 3 times a week or more 9) Subjects who was collected more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of informed consent 10) Subjects who have a history of drug dependence or alcohol dependence 11) Subjects who drink 20 g or more of pure alcohol per day for 3 days or more a week 12) Subjects who smoke 21 or more cigarettes per day on average (including e-cigarettes) 13) Shift worker or late night worker 14) Subjects who are pregnant or who intend to become pregnant during the study period or who are breastfeeding 15) Subjects who are participating in research that takes other foods or medicines, applies cosmetics or medicines or who have participated in other research within one month prior to the date of informed consent or who are willing to participate in other research 16) Subjects who are judged unsuitable for this study by the investigator, principal researcher or researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow Mediated Dilation (FMD) (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| FMD (4, 8 weeks) Urinary NOx, Urinary 8-OHdG, Urinary 8-isoPGF2a, Serum malondialdehyde (MDA), Serum plant-derived component concentration (4, 8, 12 weeks) | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management Department
Outcome results
None listed