UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031213
Receipt number R000035644
Scientific Title Long-term intervention 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 2018/02/08
Last modified on 2024/03/01 11:11:33

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Basic information

Public title

Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture

Acronym

Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture

Scientific Title

Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefecture

Scientific Title:Acronym

Long-term intervention on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake 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 by intake of lemon

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bone mineral density

Key secondary outcomes

Blood biochemical test, physical measurement, urine analysis, questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of lemon and lemon juice

Interventions/Control_2

Non-intake

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 have full ethical and regulatory approval and themselves and parental guardian give written informed consent
2.Healthy Japanese over 20 years old

Key exclusion criteria

1.Persons with the severe disease medical history
2.Persons who are allergic to the test food
3.Persons who are judged unsuitable for participating in this trial by the principal investigator

Target sample size

800


Research contact person

Name of lead principal investigator

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

150-0013

Address

4-20-1 Ebisu, Shibuya-ku, Tokyo, 150-8522 JAPAN

TEL

03-5795-1105

Email

Junichi.Tsuchiya@pokkasapporo-fb.co.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

150-0013

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 or person

Institute

POKKA SAPPORO Food & Beverage Ltd.

Institute

Department

Personal name



Funding Source

Organization

POKKA SAPPORO Food & Beverage Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

SAPPORO HOLDINGS Ltd.
Prefectural University of Hiroshima
ORTHOMEDICO Inc.
Osakikamijima-cho

Name of secondary funder(s)

SAPPORO HOLDINGS Ltd.
Prefectural University of Hiroshima


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

YES

Study ID_1

CRB3190001

Org. issuing International ID_1

Japan Registry of Clinical Trials

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 02 Month 08 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

647

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

2018 Year 01 Month 30 Day

Date of IRB

2018 Year 01 Month 30 Day

Anticipated trial start date

2018 Year 05 Month 21 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry

2023 Year 07 Month 30 Day

Date trial data considered complete

2023 Year 08 Month 30 Day

Date analysis concluded

2023 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 08 Day

Last modified on

2024 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035644


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name