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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041129
Receipt No. 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 2020/09/24

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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
Email 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
Email tetsu.prospective@gmail.com

Sponsor
Institute Numata-town
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046857

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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