UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025818 |
|---|---|
| Receipt number | 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 13:52:58 |
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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
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
kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
Sponsor or person
Institute
SAPPORO HOLDINGS Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
