UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Department of Public Health, Shiga University of Medical Science

Institute

Department

Personal name

Organization

The Japan Heart Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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.)

Date of disclosure of the study information

2016

Year

04

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

04

Month

19

Day

Last modified on

2018

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025122