UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034833
Receipt number R000039726
Scientific Title Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake
Date of disclosure of the study information 2018/11/09
Last modified on 2020/06/10 13:39:59

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Basic information

Public title

Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake

Acronym

Exploratory test on the influence of Frugra(R) intake on changes in intestinal environment and amount of salt intake

Scientific Title

Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake

Scientific Title:Acronym

Exploratory test on the influence of Frugra(R) intake on changes in intestinal environment and amount of salt intake

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Explore the influence of replacement of breakfast with Frugra(R) meal for two weeks on changes in intestinal environment and amount of salt intake before and after ingestion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Urinary indoxyl sulfate at the beginning of the test or after Frugra(R) ingestion for 2 weeks

Key secondary outcomes

Estimated amount of salt intake by spot urine at the beginning of the test or after Frugra(R) ingestion for 2 weeks


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Replace breakfast with about 50 g of Frugra(R) (Calbee, Inc.) per meal with or without milk or soy milk for two weeks

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Persons who have had urinary indoxyl sulfate test (trade name: intestinal environmental test "chokatsu check") in Healthcare Systems Co., Ltd. in the past
2.Healthy Japanese who are 20 years old
3.Choose persons whose latest urinary indoxyl sulfate value are higher from the top

Key exclusion criteria

1.Persons who are allergic to the test food
2.Persons who regularly use medicines and quasi-drugs that may affect intestinal environment such as antibiotics
3.Persons who intend to take new supplements during the exam
4.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
6.Persons who are judged inappropriate for the exam by the principal investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Yasutake

Organization

Healthcare Systems Co., Ltd.

Division name

Marketing and Sales Promotion Division

Zip code

1050004

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Email

yasutake@hc-sys.jp


Public contact

Name of contact person

1st name Takanori
Middle name
Last name Yasutake

Organization

Healthcare Systems Co., Ltd.

Division name

Marketing and Sales Promotion Division

Zip code

1050004

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Homepage URL


Email

yasutake@hc-sys.jp


Sponsor or person

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Calbee, Inc.

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

The Ethics Committee of Healthcare Systems Co., Ltd.

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

Tel

03-6809-2722

Email

soumu@hc-sys.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

2018 Year 11 Month 09 Day


Related information

URL releasing protocol

https://www.calbee.co.jp/rd/result/report38.php

Publication of results

Partially published


Result

URL related to results and publications

https://www.calbee.co.jp/rd/result/report38.php

Number of participants that the trial has enrolled

30

Results

Estimated salt intake is decreased.

Results date posted

2020 Year 06 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy Adults

Participant flow

29 participants completed

Adverse events

No adverse effect reported

Outcome measures

Estimated salt intake

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 22 Day

Date of IRB

2018 Year 10 Month 22 Day

Anticipated trial start date

2018 Year 11 Month 09 Day

Last follow-up date

2019 Year 01 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 09 Day

Last modified on

2020 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name