A study to evaluate effects of daily food containing plant extracts on chronic inflammation in an adult subject

Not Applicable

• Conditions: /A

• Registration Number: JPRN-UMIN000029095
• Lead Sponsor: House Wellness Foods Corporation Research and Development Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-11
• Study Completion: 2017-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)