UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term observation on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture
Title of the study (Brief title)	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	Toshihide Harada
Organization	Prefectural University of Hiroshima
Division name	Department of Physical Therapy
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	Kazuhiko Yoshikawa
Organization	SAPPORO HOLDINGS Ltd.
Division name	Group Research and Development Division
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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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