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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026974
Receipt No. R000030932
Scientific Title Observation study on the influence on the health of the growing period by continuous intake of lemon drinks in Osakikamijima Town, Hiroshima Prefecture
Date of disclosure of the study information 2017/04/14
Last modified on 2017/07/25

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Basic information
Public title Observation study on the influence on the health of the growing period by continuous intake of lemon drinks in Osakikamijima Town, Hiroshima Prefecture
Acronym Observation study on the influence on the health of the growing period by continuous intake of lemon drinks in Osakikamijima Town, Hiroshima Prefecture
Scientific Title Observation study on the influence on the health of the growing period by continuous intake of lemon drinks in Osakikamijima Town, Hiroshima Prefecture
Scientific Title:Acronym Observation study on the influence on the health of the growing period by continuous intake of lemon drinks 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 of growing period by intake of lemon drinks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density, Fracture rate
Key secondary outcomes Immunity improvement, vibrancy, salivary test, physical measurement, urine analysis, questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of lemon drinks containing calcium
Interventions/Control_2
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
9 years-old <=
Age-upper limit
15 years-old >=
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
Key exclusion criteria 1.Persons with the severe disease medical history
2.Persons taking antithrombotic drugs such as warfarin
3.Persons who are judged unsuitable for participating in this trial by medical doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadayuki Iida
Organization Prefectural University of Hiroshima
Division name Department of Physical Therapy
Zip code
Address 1-1, Gakuen-chou, Mihara City Hiroshima Pref., 734-8558, JAPAN
TEL 0848-60-1120
Email iida@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nakamura
Organization SAPPORO HOLDINGS Ltd.
Division name Group Research and Development Division
Zip code
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN
TEL 03-6853-6156
Homepage URL
Email Takeshi.Nakamura@sapporoholdings.co.jp

Sponsor
Institute SAPPORO HOLDINGS Ltd.
Institute
Department

Funding Source
Organization SAPPORO HOLDINGS Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor POKKA SAPPORO Food & Beverage Ltd.
Prefectural University of Hiroshima
Healthcare Systems Co., Ltd.
Osakikamijima-cho
Name of secondary funder(s) POKKA SAPPORO Food & Beverage Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 14 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
2016 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 15 Day
Last follow-up date
2020 Year 05 Month 30 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 07 Month 30 Day
Date analysis concluded
2020 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030932

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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