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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018952
Receipt No. R000021926
Scientific Title Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Date of disclosure of the study information 2017/03/31
Last modified on 2017/03/14

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Basic information
Public title Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Acronym Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Scientific Title Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Scientific Title:Acronym Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Cardiology Endocrinology and Metabolism Neurology
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It influences an oxidation stress and an age- related disease including lifestyle-related disease by absorption of the drink which included calcium richly and blended lemon juice by a longitudinal study clearly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time:11 months later
1. Subjective-objective symptom by a questionnaire
2. Somatometry
3. Blood pressure
4. Bone mineral density
5. Bone metabolism marker
6. Oxidation stress marker
Key secondary outcomes glucose and lipid metabolism
Hepatic Function
Female hormone
Fatigue

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Calcium combination lemon drink
Period: 11 months
Volume: 30 ml of lemon fruit juice and calcium 35 mg per one bottle
Frequency: 1 bottle/day
Interventions/Control_2 Calcium combination drink
Period: 11 months
Volume: 30 ml of lemon fruit juice per one bottle
Frequency: 1 bottle/day
Interventions/Control_3 No drink
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria healthy female
Key exclusion criteria 1.Person doing warfarin medicine treatment.
2.Person with the severe disease medical history.
3.The person who judged that a test responsibility doctor was unsuitable.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihide Harada
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code
Address 1-1 gakuen-machi Mihara, Hiroshima, Japan
TEL 0848-60-1257
Email hartoshi@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Ikeda
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code
Address 1-1 gakuen-machi Mihara, Hiroshima, Japan
TEL 0848-48-1180
Homepage URL
Email hikeda@pu-hiroshima.ac.jp

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor POKKA SAPPORO FOOD & BEVERAGE LTD.
Name of secondary funder(s)

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 県立広島大学(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 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
2015 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
2016 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 09 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021926

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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