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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024786
Receipt No. R000028240
Scientific Title A study to investigate effects of Peptide ingestion on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension: a randomized, double blind, placebo controlled study.
Date of disclosure of the study information 2016/11/21
Last modified on 2017/12/29

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Basic information
Public title A study to investigate effects of Peptide ingestion on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension: a randomized, double blind, placebo controlled study.
Acronym A study to assess the effects of Peptide ingestion on lowering blood pressure.
Scientific Title A study to investigate effects of Peptide ingestion on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension: a randomized, double blind, placebo controlled study.
Scientific Title:Acronym A study to assess the effects of Peptide ingestion on lowering blood pressure.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of Peptide ingestion on reducing blood pressure in high-normal blood pressure and grade 1 hypertension adult.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systolic blood pressure and diastolic blood pressure
Key secondary outcomes Pulse Wave Velocity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of peptide for 12 weeks
Interventions/Control_2 Ingestion of placebo for 12 weeks
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
65 years-old >
Gender Male and Female
Key inclusion criteria Subjects with high normal blood pressure (systolic BP from 130 to 139/ or diastolic BP from 85 to 89 mm Hg) or grade 1 hypertension (systolic BP from 140 to 159/ or diastolic BP from 90 to 99 mm Hg)
Key exclusion criteria (1) Subjects who have history or receiving treatment of serious disease
(2) Subject who is under medication for diabetes, hypertension or dyslipidemia
(3) Subject with a history of serious allergy to medicine and food
(4) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
(5) Heavy smoker and heavy drinker, or subject with irregular lifestyle
(6) Subject who is ineligible due to physician's judgment based on background of subject, physical finding, interview
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiaki Abe
Organization Morinaga Milk Industry Co., Ltd.
Division name Food Ingredients and Technology Institute
Zip code
Address 5-1-83 Higashihara Zama-Shi, Kanagawa, Japan
TEL 046-252-3070
Email f_abe@morinagamilk.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Imai
Organization CROee.INC
Division name Evidence Division
Zip code
Address 2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL 03-5953-2108
Homepage URL
Email imai@croee.com

Sponsor
Institute CROee.INC
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., Ltd.
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
2016 Year 11 Month 21 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
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 21 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
2016 Year 11 Month 10 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028240

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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