UMIN-CTR Clinical Trial

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 Tadayuki Middle name Last name Iida
Organization	Prefectural University of Hiroshima
Division name	Department of Physical Therapy
Zip code	723-0053
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 Junichi Middle name Last name Tsuchiya
Organization	POKKA SAPPORO Food & Beverage Ltd.
Division name	Business Planning Dept. All Lemon Business Group
Zip code	150-8522
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	Self funding
Nationality of Funding Organization

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

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	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	28
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	2016 Year 11 Month 16 Day
Anticipated trial start date	2017 Year 04 Month 15 Day
Last follow-up date	2020 Year 12 Month 06 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 07 Month 30 Day
Date analysis concluded	2021 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 13 Day
Last modified on	2021 Year 04 Month 12 Day

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