UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018952 |
|---|---|
| Receipt number | 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 08:53:10 |
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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
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
hikeda@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021926
