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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031213
Receipt No. R000035644
Scientific Title Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Date of disclosure of the study information 2018/02/08
Last modified on 2020/09/01

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Basic information
Public title Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Acronym Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Scientific Title Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Scientific Title:Acronym Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Region
Japan

Condition
Condition Normal healthy subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Observation of influence on health condition by intake of lemon
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density
Key secondary outcomes Blood biochemical test, physical measurement, urine analysis, questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of lemon and lemon juice
Interventions/Control_2 Non-intake
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Persons who have full ethical and regulatory approval and themselves and parental guardian give written informed consent
2.Healthy Japanese over 20 years old
Key exclusion criteria 1.Persons with the severe disease medical history
2.Persons who are allergic to the test food
3.Persons who are judged unsuitable for participating in this trial by the principal investigator
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Tsuchiya
Organization POKKA SAPPORO Food & Beverage Ltd.
Division name Business Planning Dept. All Lemon Business Group
Zip code 150-0013
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN
TEL 03-5795-1105
Email Junichi.Tsuchiya@pokkasapporo-fb.co.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Tsuchiya
Organization POKKA SAPPORO Food & Beverage Ltd.
Division name Business Planning Dept. All Lemon Business Group
Zip code 150-0013
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN
TEL 03-5795-1105
Homepage URL
Email Junichi.Tsuchiya@pokkasapporo-fb.co.jp

Sponsor
Institute POKKA SAPPORO Food & Beverage Ltd.
Institute
Department

Funding Source
Organization POKKA SAPPORO Food & Beverage Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor SAPPORO HOLDINGS Ltd.
Prefectural University of Hiroshima
ORTHOMEDICO Inc.
Osakikamijima-cho
Name of secondary funder(s) SAPPORO HOLDINGS Ltd.
Prefectural University of Hiroshima

IRB Contact (For public release)
Organization The Research Ethics Committee of POKKA SAPPORO Food & Beverage Ltd.
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN
Tel 03-5795-1105
Email Toshihiro.Takahashi@pokkasapporo-fb.co.jp

Secondary IDs
Secondary IDs YES
Study ID_1 CRB3190001
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 08 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 30 Day
Date of IRB
2018 Year 01 Month 30 Day
Anticipated trial start date
2018 Year 05 Month 21 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
2023 Year 07 Month 30 Day
Date trial data considered complete
2023 Year 08 Month 30 Day
Date analysis concluded
2023 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 08 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035644

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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