UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021982
Receipt No. R000025122
Scientific Title A pilot-phase randomized crossover trial of Japanese style DASH (Dietary Approaches to Stop Hypertension) diet
Date of disclosure of the study information 2016/04/20
Last modified on 2018/04/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A pilot-phase randomized crossover trial of Japanese style DASH (Dietary Approaches to Stop Hypertension) diet
Acronym A pilot-phase randomized crossover trial of Japanese style DASH (Dietary Approaches to Stop Hypertension) diet
Scientific Title A pilot-phase randomized crossover trial of Japanese style DASH (Dietary Approaches to Stop Hypertension) diet
Scientific Title:Acronym A pilot-phase randomized crossover trial of Japanese style DASH (Dietary Approaches to Stop Hypertension) diet
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessing the feasibility of a future large sample dietary intervention study and efficacy of the Japanese style DASH diet on urinary sodium-to-potassium ratio, blood pressure and cardiometabolic risk factors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility
1. 24-hour urinary sodium and potassium excretion on the last day of each intervention period
2. Dietary adherence
Key secondary outcomes Effects of DASH diets for Japanese on blood pressure, anthropometric and biomarkers
1. Home blood pressure
2. Office blood pressure
3. Body weight, height, blood lipids, blood glucose, insulin, hs-CRP, aldosterone-to-renin ratio, catecholamine

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 First intervention period: Consumption of Japanese style DASH diet for 3 weeks
Washout period: Consumption of usual diet in each participant for more than a week
Second intervention period: Consumption of Control diet (typical Japanese diet) for 3 weeks

Consumption of test diet (Japanese style DASH diet or control diet) at breakfast, lunch, dinner and snacks on weekdays.
Interventions/Control_2 First intervention period: Consumption of Control diet (typical Japanese diet) for 3 weeks
Washout period: Consumption of usual diet in each participant for more than a week
Second intervention period: Consumption of Japanese style DASH diet for 3 weeks

Consumption of test diet (Japanese style DASH diet or control diet) at breakfast, lunch, dinner and snacks on weekdays.
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy volunteer
2) No use of antihypertensive drugs
3) Likely to be able to take breakfast, lunch, dinner and snacks at the research restaurant
Key exclusion criteria 1) Use of antihypertensive drugs
2) Special dietary requirements (low energy, low potassium, etc)
3) Food allergy
4) Pregnant and breastfeeding women
5) Diagnosed with dementia
6) Other medical conditions that can affect assessment of outcomes
7) Undergraduate students of Shiga University of Medical Science
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Miyagawa
Organization Shiga University of Medical Science
Division name Department of Public Health
Zip code
Address Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL 077-548-2191
Email naocom@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Miyagawa
Organization Shiga University of Medical Science
Division name Department of Public Health
Zip code
Address Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL 077-548-2191
Homepage URL
Email naocom@belle.shiga-med.ac.jp

Sponsor
Institute Department of Public Health, Shiga University of Medical Science
Institute
Department

Funding Source
Organization The Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 滋賀医科大学アジア疫学研究センター(滋賀県)/ Center for Epidemiologic Research in Asia, Shiga University of Medical Science (Shiga Pref.)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 20 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 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 04 Month 19 Day
Last modified on
2018 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025122

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.