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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025818
Receipt No. R000029692
Scientific Title Long-term observation 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 2018/12/31
Last modified on 2018/03/15

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

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the effects on bone mineral density and of lifestyle related diseases prevention by daily intake of lemon.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone density
Key secondary outcomes Bone metabolism, Glucose and Lipid metabolism, Hepatic function, Immune function, Renal function, Oxidative Stress, Blood pressure, Body weight, Sleep Quality, Fatigue

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Persons who give written informed consent, and have full ethical and regulatory approval
Key exclusion criteria 1. Persons treating osteoporosis
2. Persons with the severe disease medical history
3. Persons who are judged unsuitable for participating in this trial by physician
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihide Harada
Organization Prefectural University of Hiroshima
Division name Department of Physical Therapy
Zip code
Address 1-1-71 Ujina-Higashi, Minami-ku, Hiroshima City Hiroshima Pref., 734-8558, JAPAN
TEL 082-251-5178
Email hartoshi@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Yoshikawa
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 03-5795-1201
Homepage URL
Email kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Sponsor
Institute SAPPORO HOLDINGS Ltd.
Institute
Department

Funding Source
Organization None
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
2018 Year 12 Month 31 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
2016 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information This study is a noninterventional observational study, and aims to analyze the relationship between daily lemon intake and health status and clarify the effectiveness of daily lemon intake. Study subjects target adult men and women living in Osakikamijima town. The subjects are recruited through the Osakikamijima town office and the Japan Agricultural Cooperatives.

Management information
Registered date
2017 Year 01 Month 24 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029692

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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