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A clinical study for the effects of a plant extract on improving vascular endothelial function - Randomized, double-blind, placebo-controlled parallel-group comparative study

A clinical study for the effects of a plant extract on improving vascular endothelial function - Randomized, double-blind, placebo-controlled parallel-group comparative study - A clinical study for the effects of a plant extract on improving vascular endothelial function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038722
Enrollment
54
Registered
2019-11-30
Start date
2020-02-10
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 Individuals

Interventions

Inatake of the food containing paprika-xanthophyll 9mg (once a day, 12weeks) Intake of the placebo foods (once a day, 12weeks)

Sponsors

Ezaki Glico Co., Ltd.
Lead Sponsor
Graduate school of Agricultural Sciences, Tohoku University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Subjects whose LDL-cho is is relatively high. (2)Subjects whose FMD is 0% or more and less than 6.0%. (3)Subjects whose BMI is 25.0 or more and less than 30.0. (4)Subjects who can visit the clinic facility on the scheduled visit date. (5)Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: (1) Subjects who have received some kind of treatment or care at the time of study participation. (2)Subjects who are during pregnancy or lactation, and intend to be pregnant during the study period. (3)Subjects who have a smoking habit (4)Subjects having blood sample of 200 mL within 4 week at the start of this study. (5)Subjects having blood sample of 400 mL within 16 week at the start of this study. (6)Subjects having blood sample of 1000 mL or more than within 48 hours at the start of intake of test food. (7)Subject in other clinical trials or trials. (8)Subjects who fall under any of the following items. a. Subjects who have heart, liver, or kidney disease (including complications of other diseases) b.Subjects with a history of cardiovascular disease. c.Subjects who have diabetes. d. Subjects with or having a history of serious diseases such as cancer and asthma. (9)Subjects who have a history of major surgery in the gastrointestinal tract such as gastrectomy, gastrointestinal suture, and intestinal resection. (10)Subjects who have severe food allergies. (11)Subjects who regularly use supplements, vegetable juice, and tomato juice that have the same ingredients as the test food. (12)Subjects who cannot refrain from taking Citrus unshiu during the test period (including the pre-observation period). (13)Subjects determined to be inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Flow-mediated dilation

Countries

Japan

Contacts

Public ContactMasakazu Tomaru

Synapse Planning co.Ltd. Clinical Trial Session

tomaru@khh.biglobe.ne.jp03-5604-9442

Outcome results

None listed

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