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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029095
Receipt No. R000033280
Scientific Title A study to evaluate effects of daily food containing plant extracts on chronic inflammation in an adult subject
Date of disclosure of the study information 2017/09/11
Last modified on 2019/07/12

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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

Other
Other related information

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2019 Year 07 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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