UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044168
Receipt number R000050437
Scientific Title Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Date of disclosure of the study information 2021/05/12
Last modified on 2022/03/31 11:50:41

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Basic information

Public title

Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)

Acronym

Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)

Scientific Title

Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)

Scientific Title:Acronym

Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to verify that tomato affect Na/K urinary ratio and body water content, we compared between tomato recommended population on dietary intervention and non-intervening population as part of the nutritional survey of Na/K urinary ratio and body water content

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body composition measurement
the measurement of Na/K urinary ratio in 24-hour urine collection

Key secondary outcomes

Dietary record
Food Frequency Questionnaire
Blood pressure measurement


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subject who are assigned to the dietary intervention group is received national registered dietitian's dietary intervention, then they include tomatoes in their diet for 10 days before urine collection

Interventions/Control_2

control

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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Female

Key inclusion criteria

(1)Women aged between 20 to 65 years old
(2)Relatively healthy person, especially, no heart disease
(3)Subject who can collect urine for 24 hours
(4)Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.

Key exclusion criteria

(1)Subject who could not record diet
(2)Subject who could not collect urine properly
(3)Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Mariko
Middle name
Last name Morita

Organization

Shokei University

Division name

Department of Life Science

Zip code

862-8678

Address

2-6-78 Kuhonji, Chuo-ku, Kumamoto

TEL

096-362-2011

Email

m_morita@syokei-gakuen.ac.jp


Public contact

Name of contact person

1st name Hirokazu
Middle name
Last name Toubou

Organization

Shinshu university

Division name

school of medicine

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2622

Homepage URL


Email

htoubou@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Life Science, Shokei University, Kumamoto, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Life Science, Shokei University, Kumamoto, Japan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shokei University

Address

2-6-78 Kuhonji, Chuo-ku, Kumamoto

Tel

096-362-2011

Email

sakata@shokei-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



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 12 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

10

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

2021 Year 03 Month 01 Day

Date of IRB

2021 Year 04 Month 20 Day

Anticipated trial start date

2021 Year 05 Month 12 Day

Last follow-up date

2021 Year 10 Month 01 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 11 Day

Last modified on

2022 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050437


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name