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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027726
Receipt No. 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

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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
Email 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
Email tomiyama@tokyo-med.ac.jp

Sponsor
Institute Department of cardiology, Tokyo medical university
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031767

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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