Effects of consumption of the test food on the vascular endothelial function in healthy Japanese subjects

Effects of consumption of the test food on the vascular endothelial function in healthy Japanese subjects: an open-label trial - Effects of consumption of the test food on the vascular endothelial function in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050126

Enrollment

Registered

2023-01-25

Start date

2023-01-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Capsule containing freeze-dried Aurantiochytrium Administration: Take one capsule with water once daily *If you forget to take the test food, take it as soon as you

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more and less than 65 4. Healthy subjects 5. Subjects whose FMD values are 6% or more at screening (before consumption: Scr) 6. Subjects whose FMD values are relatively low at Scr

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who usually take food/beverage with functional ingredients which may influence the vascular function (e.g., procyanidin, lactotripeptide, black soybean polyphenols, elastin peptides, Bifidobacterium lactis LKM512, arginine, or geniposidic acid) 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are smokers 9. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 10. Subjects who suffer from COVID-19 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. Flow-mediated dilation (FMD) at 12 weeks after consumption (12w)	—

Secondary

Measure	Time frame
1. Maximum expansion width of the blood vessel and the resting vessel diameter at 12w	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026