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Examination of the effect of test food intake on improving vascular function in healthy adults-Randomized, double-blind, placebo-controlled, parallel-group study-

Examination of the effect of test food intake on improving vascular function in healthy adults-Randomized, double-blind, placebo-controlled, parallel-group study- - Examination of the effect of test food intake on improving vascular function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049050
Enrollment
66
Registered
2024-03-31
Start date
2022-10-06
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

None (Healthy adults)

Interventions

Intakes of test food for 12 weeks Intakes of placebo food for 12 weeks

Sponsors

Kirin Holdings Company, Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Men and women in good health who are between 45 and 70 years old: Women are limited to postmenopausal (Duration of amenorrhea; >1 y) (2) Subjects whose FMD values of 5.5% >= (3) Subjects whose baPWV values of 1400 cm/sec <= (4) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and are able to provide a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who have been diagnosed with heart disease, liver disease, kidney disease, respiratory disease, endocrine disease, metabolic disease, or a history of these diseases (2) Subjects who have the disease under treatment (3) Subjects who regularly use supplements, health food (including foods for specified health use / foods with functional claims) during the test period (4) Subjects who have currently been taking medicines, supplements / health foods or cosmetics with any functional claims such as L-citrulline, L-arginine, L-ornithine, procyanidins, bonito elastin, linolenic acid, DHA, EPA, CoQ10, nattokinase, lutein, blueberries, cassis, vitamin E, ginkgo biloba extract, melilot, polyphenols (hesperidin, flavangenol, pycnogenol etc.) (5) Subjects who have currently been taking medicines, supplements / health foods or cosmetics for the purpose of improving blood flow and blood pressure in addition to the ingredients listed in (4) (6) Subjects who take part in another clinical study during the study, or who have participated as subjects in another clinical trials within the past 3 months (7) Subjects who are excessively take alcohol (expressed in an amount of alcohol: over 20g/day) (8) Subjects who have a smoking habit (those who smoke daily or occasionally in the last 3 months) (9) Subjects who conduct hormone replacement therapy in the 3 months. (10) Asthma patients (11) Subjects who have severe anemia (12) Subjects who have multiple irregularities in their lives during the research period due to day / night shift work or night work, or those who are engaged in physical labor such as transporting heavy objects. (13) Subjects who have been pregnant , or have a plan to breast feed during the study period (14) Subjects who are judged by the investigator to be inappropriate as subjects based on the test results at the time of screening (15) Subjects deemed unsuitable by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Vascular function

Secondary

MeasureTime frame
Subjective feelings evaluation Blood pressure Blood analysis

Countries

Japan

Contacts

Public ContactMasakazu Tomaru

Synapse Planning Company, Limited. Clinical Trial Session

tomaru@synaps.co.jp03-5604-9442

Outcome results

None listed

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