UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027726 |
|---|---|
| Receipt number | R000031767 |
| Scientific Title | The evaluation of the effects of CAsein hydroLysate containing milk-derived Peptides on vascular function and blood pressure |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2018/12/13 07:32:29 |
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Basic information
Public title
The evaluation of the effects of CAsein hydroLysate containing milk-derived Peptides on vascular function and blood pressure
Acronym
CALP study
Scientific Title
The evaluation of the effects of CAsein hydroLysate containing milk-derived Peptides on vascular function and blood pressure
Scientific Title:Acronym
CALP study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of CAsein hydroLysate containing milk-derived Peptides on vascular function and blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
home blood pressure, blood pressure, vascular function
Key secondary outcomes
renal function
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
CAsein hydroLysate containing milk-derived Peptides
Interventions/Control_2
placebo
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
casual blood pressure under treatment <150/90 mmHg
Key exclusion criteria
cardiovascular disease/ malignancy
allergy for milk
atrial fibrillation
chronic kidney disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Tomiyama |
Organization
Tokyo medical university
Division name
cardiology
Zip code
Address
6-7-1 nishishinjuku, shinjuku-ku, tokyo
TEL
03-3342-6111
tomiyama@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Tomiyama |
Organization
Tokyo medical university
Division name
cardiology
Zip code
Address
6-7-1 nishishinjuku, shinjuku-ku, tokyo
TEL
03-3342-6111
Homepage URL
tomiyama@tokyo-med.ac.jp
Sponsor or person
Institute
Department of cardiology, Tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
Asahi Calpis wellness Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031767
