UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041129 |
|---|---|
| Receipt number | R000046857 |
| Scientific Title | Effect of tomato juice and hot spring water of Numata-town for prevention of life-style diseases |
| Date of disclosure of the study information | 2020/07/16 |
| Last modified on | 2021/02/16 23:51:54 |
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Basic information
Public title
The research for making health brand of Numata-town using town's resource and ubiquinol
Acronym
Numata-town health brand project
Scientific Title
Effect of tomato juice and hot spring water of Numata-town for prevention of life-style diseases
Scientific Title:Acronym
Effect of tomato juice and hot spring water of Numata-town for prevention of life-style diseases
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By health activities using Numata-town's resources, we try to promote the prevention of life-style diseases and to increase health awareness of residents in order to making town's healthy brand.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, LDL-cholesterol
Key secondary outcomes
Cognitive function, mobility function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
For 12 weeks, the participants drink one bottle of tomato juice (190 g) per day.
Interventions/Control_2
For 12 weeks, the participants drink one bottle of tomato juice (190 g) per day and consume ubiquinol capsules (100 mg) after meal every day.
Interventions/Control_3
For 12 weeks, the participants drink 150 ml of hot spring water twice a week (if possible, three or four times a week).
Interventions/Control_4
For 12 weeks, the participants drink 150 ml of hot spring water twice a week (if possible, three or four times a week), and consume ubiquinol capsules (100mg) after meal every day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The residents of Numata-town
(2) 20 years old or over
(3) The residents who can participate in the scheduled examination session and can visit designated facility.
(4) Applicants who understand well the purpose and contents of this examination. Additionaly, who can agree to participate in this examination in writing.
Key exclusion criteria
(1) Have allergy against tomato juice, hot spring water, or ubiquinol supplmement.
(2) Pregnant or nursing.
(3) Who have participated in other clinical trials within 3 months.
(4) Who daily consume supplements or foods containing coenzyme Q10.
(5) Who daily drink tomato juice over twice a week.
(6) Who daily drink hot spring water twice a week.
(7) Others who are judged to be ineligible by the investigator and co-workers.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yokoyama |
Organization
Numata-town
Division name
Mayor
Zip code
078-2202
Address
South 1-3-6-53, Numata-town, Hokkaido
TEL
0164-35-2155
sangyou@town.numata.lg.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Institute of Social Epidemiology
Zip code
791-0243
Address
1383-2, Hiraimahi, Matsuyama-city
TEL
089-904-7811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Numata-town
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Pioneering Survey and Demonstration Project
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinikai Hospital IRB
Address
11-186, Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
0117711501
info@yurinokai.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
| 2020 | Year | 07 | Month | 16 | 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
38
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
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
