UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate effects of daily food containing plant extracts on chronic inflammation in an adult subject
Acronym	Effects of plant extracts on chronic inflammation in an adult subject
Scientific Title	A study to evaluate effects of daily food containing plant extracts on chronic inflammation in an adult subject
Scientific Title:Acronym	Effects of plant extracts on chronic inflammation in an adult subject
Region	Japan

Condition
Condition	N/A
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine the effect of 12-weeks ingestion of a food containing plant extracts for improving chronic inflammation in an adult males and females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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)
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product with a plant extract (3 tablets per a day; 12 weeks)
Interventions/Control_2	Oral ingestion of the test product without a plant extract (3 tablets per a day; 12 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key 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.
Key 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
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Yamamoto
Organization	House Wellness Foods Corporation
Division name	Research and Development Institute
Zip code	664-0011
Address	Imoji 3-20, Itami, Hyogo
TEL	072-778-1121
Email	Yamamoto_Yoshihiro@house-wf.co.jp

Public contact
Name of contact person	1st name Ryusei Middle name Last name Uchio
Organization	House Wellness Foods Corporation
Division name	Research and Development Institute
Zip code	664-0011
Address	Imoji 3-20, Itami, Hyogo
TEL	072-778-1127
Homepage URL
Email	Uchio_Ryusei@house-wf.co.jp

Sponsor
Institute	House Wellness Foods Corporation Research and Development Institute
Institute
Department

Funding Source
Organization	House Wellness Foods Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of the Chiyoda Paramedical Care Clinic
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 08 Day
Date of IRB	2017 Year 08 Month 24 Day
Anticipated trial start date	2017 Year 09 Month 12 Day
Last follow-up date	2017 Year 12 Month 12 Day
Date of closure to data entry	2018 Year 01 Month 24 Day
Date trial data considered complete	2018 Year 02 Month 08 Day
Date analysis concluded	2018 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 11 Day
Last modified on	2019 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033280