UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020449
Receipt number R000023629
Scientific Title Benefit study of traditional Japanese diet 2
Date of disclosure of the study information 2016/01/12
Last modified on 2020/02/17 17:51:40

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Basic information

Public title

Benefit study of traditional Japanese diet 2

Acronym

The effect of Japanese diet on the sleep, stress, motor function and metabolism

Scientific Title

Benefit study of traditional Japanese diet 2

Scientific Title:Acronym

The effect of Japanese diet on the sleep, stress, motor function and metabolism

Region

Japan


Condition

Condition

Healthy aduits

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The effect of Japanese diet on the sleep, stress, motor function and metabolism

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Basic athletic ability test (shuttle run, standing triple jump, throwing medicine ball)

Key secondary outcomes

/Sleep and Stress Quality-related Questionnaire and measurement Items
/Body weight, body mass index, visceral fat mass
/Hematological and biochemical evaluation by blood examination, bioactive molecules
/Intestinal bacteria
/Gene expression changes and epigenetic changes in blood cells


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects take the test food(1975 Japanese diet) and perform the exercise three times a week [moderate of more than 1 hour] during 4 weeks.

Interventions/Control_2

The subjects take the test food(Modern Japanese diet) and perform the exercise three times a week [moderate of more than 1 hour] during 4 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

20 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Aged 20-40 years at informed consent
2) Body-mass index (BMI) 18.5-25 kg/m2
3) Obtained written informed consent from the subjects for the study participation

Key exclusion criteria

1) Pregnancy, nursing or planning to become pregnant during the study (female only)
2) Any other significant medical conditions
3) Uncontrolled metabolic syndrome
4) Severe allergies
5) Participation in other clinical trials at enrollment
6) Any other considered by a study physician to be inappropriate for inclusion

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Tsuduki

Organization

Tohoku University

Division name

Graduate School of Agricultural Science

Zip code

980-0802

Address

468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan

TEL

022-757-4392

Email

tsudukit@tohoku.ac.jp


Public contact

Name of contact person

1st name Tsuyoshi
Middle name
Last name Tsuduki

Organization

Tohoku University

Division name

Graduate School of Agricultural Science

Zip code

980-0802

Address

468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan

TEL

022-757-4392

Homepage URL


Email

tsudukit@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

National Agriculture and Food Research Organization

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Ethics Committee

Address

468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0802, Japan

Tel

022-757-4392

Email

tsudukit@tohoku.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

東北大学(宮城県)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 12 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jos/67/5/67_ess17259/_article

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jos/67/5/67_ess17259/_article

Number of participants that the trial has enrolled

32

Results

Body weight, body fat percentage, body fat mass, serum triglyceride level, and serum low-density lipoprotein cholesterol level were significantly decreased and serum high-density lipoprotein cholesterol and serum magnesium levels were significantly increased in 1975 Japanese diet group. These results showed that a diet with the characteristics of the 1975 Japanese diet has a beneficial effect on lipid metabolic parameters.

Results date posted

2020 Year 02 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Subjects aged 20-29 years old

Participant flow

Subjects aged 20~29 years old were randomly assigned to the MD (n=16) and JD (n=16) groups. Each subject consumed the diet three times a day for 28 days.

Adverse events

None

Outcome measures

Changes in physical conditions, including body composition and blood biochemistry, from before to after the study period were evaluated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB

2015 Year 12 Month 07 Day

Anticipated trial start date

2015 Year 12 Month 08 Day

Last follow-up date

2016 Year 02 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 06 Day

Last modified on

2020 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name