MedPath

Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Not Applicable
Conditions
Healthy Adult
Registration Number
JPRN-UMIN000048020
Lead Sponsor
Hokkaido Information University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

1.Subjects with difficulty measuring flow- mediated dilation. 2.Subjects whose BMI is >=30 kg/m2. 3.Subjects who are under physician's advice, treatment, and/or medication for hypertension, dyslipidemia and/or diabetes. 4.Subjects with implantable electronic medical devices. 5.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 6.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8.Subjects with severe anemia. 9.Pre- or post-menopausal women complaining of obvious physical changes. 10.Subjects who are at risk of having allergic reactions to drugs or foods. 11.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood vessel function and/or blood pressure. 12.Smokers, alcohol addicts or subjects with disordered lifestyle. 13.Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 14.Pregnant or lactating women or women who expect to be pregnant. 15.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 16.Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Flow-mediated dilation
Secondary Outcome Measures
NameTimeMethod
Sleep and stress questionnaires, home blood pressure
© Copyright 2025. All Rights Reserved by MedPath