None listed
Conditions
Interventions
Oral ingestion of the test product with a plant extract (3 tablets per a day
12 weeks)
Oral ingestion of the test product without a plant extract (3 tablets per a day
Sponsors
House Wellness Foods Corporation Research and Development Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) An adult males and females from 50 to 69 years of age (2) Subjects whose BMI values are between normal-high and obesity class 1 (>=23 and <30) or blood pressure are between normal and grade 1 hypertension (systolic blood pressure (SBP); >=120 and 160< or diastolic blood pressure (DBP); 80>= and 100<) (3) Subjects who do not have any problem such as arm numbness during measurement of endothelial function (4) Subjects who participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects whose HCV antibody or HbsAg are positive (2) Subjects who consecutively intake pharmaceutical or healthcare food which is possible to influence the result of this study (3) Subjects who have a history of heart disease, liver disease, kidney, or digestive system disease (4) Subjects who have a history of cardiovascular disease (5) Subjects who have excessive alcohol-drinking or smoking habit (6) Subjects who have extremely irregular dietary habits (7) Subjects who have medication or food allergy (8) Subjects who are participating in other trial, have participated in the past 4 weeks, or plan to participate in other trial during scheduled period in this trial (9) Subjects who have made a blood donation within the last one month prior to this study (10) Male subjectss who have made a blood donation of 400 mL within the last three months prior to this study (11) Female subjects who have made a blood donation of 400 mL within the last four months prior to this study (12) Male subjects who have made a blood donation over an amout (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (13) Female subjects who have made a blood donation over an amout (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (14) Subjects judged as unsuitable for the study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 0, 4, 8, 12 weeks in the intervention (1) C-reactive protein (CRP) (2) Tumor necrosis factor (TNF)-alpha (3) Interleukin (IL)-6 (4) Interleukin (IL)-1beta (5) Soluble vascular cell adhesion molecule-1 (sVCAM-1) | — |
Secondary
| Measure | Time frame |
|---|---|
| At 0, 4, 8, 12 weeks in the intervention (1) Hemoglobin A1c (HbA1c) (2) Uric acid (UA) (3) Malondialdehyde modified LDL (MDA-LDL) (4) Urinary 8-Hydroxydeoxyguanosine (8-OHdG) (5) Flow mediated dilation (FMD) (6) Reactive hyperemia peripheral arterial tonometry (RH-PAT; At 0, 12 weeks in the intervention) (7) Acceleration plethysmogram (8) Profile of mood states-2nd edition (POMS-2) short versions (9) MOS 36-Item short form version 2 (SF-36v2; acute) (10) Visual analogue scale (VAS) | — |
Countries
Japan
Contacts
Public ContactRyusei Uchio
House Wellness Foods Corporation Research and Development Institute
Outcome results
None listed