UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018992 |
|---|---|
| Receipt number | R000021966 |
| Scientific Title | Effects of the WASHOKU-based Dietary Approach to Stop Hypertensin Diet and Fish Humbergur on Blood Pressure and Cardiac Risk Factors in Subjects with Untreated High Normal Blood Pressure and Stage 1 Hypertension |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2021/06/03 11:37:14 |
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Basic information
Public title
Effects of the WASHOKU-based Dietary Approach to Stop Hypertensin Diet and Fish Humbergur on Blood Pressure and Cardiac Risk Factors in Subjects with Untreated High Normal Blood Pressure and Stage 1 Hypertension
Acronym
Effects of the WASHOKU-based DASH Diet and Fish Humbergur on Blood Pressure and Cardiac Risk Factors in Subjects with Untreated High Normal Blood Pressure and Stage 1 Hypertension
Scientific Title
Effects of the WASHOKU-based Dietary Approach to Stop Hypertensin Diet and Fish Humbergur on Blood Pressure and Cardiac Risk Factors in Subjects with Untreated High Normal Blood Pressure and Stage 1 Hypertension
Scientific Title:Acronym
Effects of the WASHOKU-based DASH Diet and Fish Humbergur on Blood Pressure and Cardiac Risk Factors in Subjects with Untreated High Normal Blood Pressure and Stage 1 Hypertension
Region
| Japan |
Condition
Condition
high normal BP and stage 1 hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess the effects of the WASHOKU-based DASH diet on blood pressure and cardiometabolic factors in subjects with both untreated high normal BP and stage 1 hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Reduction of blood pressure after 2-month intervention
Key secondary outcomes
Change of body weight, lipid, glucose, behavior point scale change, EPA/AA ratio
Blood pressure variability
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
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
cereal only 1 time
Interventions/Control_2
cereal+Washoku-based DASH diet 1 time/day
Interventions/Control_3
cereal+cereal+Washoku-based DASH diet 2 times/day
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
High normal blood pressure and stage I hypertension
Unteated
Capable of home blood pressure 2 times in a day
Key exclusion criteria
Secondary hypertension
Chronic kidney disease (stage 3b and more)
Previous history of cardiovascular disease
Hormone replace therapy
Diagnosed as Dementia
Diabetes treated with sulfonilurea or insulin
Liver dysfunction
Food allergy
Pregnancy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Umemoto |
Organization
Hiroshima University hospital
Division name
Clinical Research Center in Hiroshima
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima Japan
TEL
082-257-1542
umemoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Yagi |
Organization
Medical Software Laboratory
Division name
Ube section
Zip code
755-0067
Address
361-1 Majime Kogushi Ube, Yamaguchi Japan
TEL
0836-37-1300
Homepage URL
http://ds.cc.yamaguchi-u.ac.jp/~crc-di/frame.html
hyagi@mslabo.co.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Maruha Nichiro Corporation
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Center for Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Japan
Tel
0836-22-2428
clin_res@yamaguchi-u.ac.jp
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
尾中病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33298663/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33298663/
Number of participants that the trial has enrolled
51
Results
The J-DASH diet was feasible to improve home BP and stabilize its variability, and it did so more effectively than the participants' usual diets.
Results date posted
| 2021 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 09 | Day |
Baseline Characteristics
The participants' mean age was 50 years, and 44% were women.
Participant flow
The participants were recruited through advertisements in local newspapers and our website and from among randomized participants at Yamaguchi University Hospital. The 2-month treatments included the following: the J-DASH-1 diet 1x/day or the J-DASH-2 diet providing a fish hamburger-patty 2x/day (5 days/week respectively).
Adverse events
No
Outcome measures
The main outcome measure was the feasibility of the J-DASH diet. We also collected the data of clinic BP and home BP (by automatic BP monitor), cardiometabolic biomarkers, and lifestyle and psychosocial parameters during the intervention phase. We examined behavior changes throughout the study period, and the diets' safety.
Plan to share IPD
Only academia research group will be considered and will be provided the data depend upon the contents of the request.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021966
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