UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041954
Receipt number R000047886
Scientific Title Study on the absorption and urinary excretion of minerals from vegetable juices
Date of disclosure of the study information 2020/10/01
Last modified on 2021/09/29 13:04:57

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Basic information

Public title

Study on the absorption and urinary excretion of minerals from vegetable juices

Acronym

Study on the absorption and urinary excretion of minerals from vegetable juices

Scientific Title

Study on the absorption and urinary excretion of minerals from vegetable juices

Scientific Title:Acronym

Study on the absorption and urinary excretion of minerals from vegetable juices

Region

Japan


Condition

Condition

healthy

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Understanding the effect of vegetable juice intake on the urinary sodium/potassium ratio

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

urinary sodium/potassium ratio

Key secondary outcomes

Salt intake estimates


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of tomato-containing vegetable juice (7 days) > Washout (3 days) > Intake of concentrated vegetable juice (7 days) > Washout (3 days) > Intake of vegetable juice (7 days)

Interventions/Control_2

Intake of concentrated vegetable juice (7 days) > Washout (3 days) > Intake of vegetable juice (7 days) > Washout (3 days) > Intake of tomato-containing vegetable juice (7 days)

Interventions/Control_3

Intake of vegetable juice (7 days) > Washout (3 days) > Intake of tomato-containing vegetable juice (7 days) > Washout (3 days) >Intake of concentrated vegetable juice (7 days)

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Healthy Japanese men or postmenopausal Japanese women, the ages of more than 20 years old and less than 65 years old
2) Subjects who can fill out a web survey with a smartphone or iPhone
3) Subjects who get the sufficient explanation of the purpose and content of this study, have the ability to consent, voluntarily apply with the sufficient understanding, and approve of the participation in the document

Key exclusion criteria

1) Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases/disorders
2) Subjects who have diseases/disorders with continuous medical treatment or have medical history of severe diseases/disorders needed medical treatment
3) Subjects who receive medical treatment for digestive diseases/disorders which affect this study, or have surgical history of digestive system (except appendectomy)
4) Subjects with food allergies to ingredients in vegetable juices used in this study
5) Subjects who have received dietary guidance on potassium from a doctor or nutritionist
6) Subjects who habitually drink vegetable juices at least three times a week
7) Subjects who have been watching salt reduction and prefer a lighter taste
8) Any candidate considered to be unsuitable for enrollment based on his/her answers of lifestyle questionnaire
9) Subjects who had participated in other clinical trials including drug and food within 1 month
10) Subjects who are judged as inappropriate by investigators

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Ushida

Organization

KAGOME CO., LTD.

Division name

Innovation Division

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobara-shi, Tochigi, Japan

TEL

0287-36-2935

Email

Yusuke_Ushida@kagome.co.jp


Public contact

Name of contact person

1st name Shigeru
Middle name
Last name Imai

Organization

Leverage Brain Inc.

Division name

Clinical Trial Department

Zip code

105-0004

Address

2-16-1 Shinbashi Minato-ku, Tokyo, Japan

TEL

080-7290-0404

Homepage URL


Email

imai@levbrain.com


Sponsor or person

Institute

KAGOME CO., LTD

Institute

Department

Personal name



Funding Source

Organization

KAGOME CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Conference of Clinical Research (JCCR)

Address

1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan

Tel

03-6868-7022

Email

jccr-info@cts-smo.com


Secondary IDs

Secondary IDs

YES

Study ID_1

2020-R12

Org. issuing International ID_1

The Ethics Committee of KAGOME CO., LTD.

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 01 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

Completed

Date of protocol fixation

2020 Year 09 Month 30 Day

Date of IRB

2020 Year 09 Month 30 Day

Anticipated trial start date

2020 Year 10 Month 02 Day

Last follow-up date

2020 Year 11 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 30 Day

Last modified on

2021 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047886


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name