UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029095 |
|---|---|
| Receipt number | 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 | 2019/11/07 10:50:20 |
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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
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
Uchio_Ryusei@house-wf.co.jp
Sponsor or person
Institute
House Wellness Foods Corporation Research and Development Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033280
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