UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046615
Receipt number R000053157
Scientific Title A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption
Date of disclosure of the study information 2022/01/12
Last modified on 2022/12/26 09:30:44

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Basic information

Public title

A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption

Acronym

A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption

Scientific Title

A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption

Scientific Title:Acronym

A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A comparative study to evaluate changes in intestinal environment induced by different test -foods consumption

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Average number of defecation per week and Gut microbiota analysis,before ingestion and 4 weeks after ingestion.

Key secondary outcomes

1)Defecation characteristics (defecation frequency, number of defecation, quantity, shape, incomplete evacuation, fecal odor)
2)Average number of tablets of the magnesium carbonate which ingested per week ,before ingestion and 4 weeks after ingestion.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingest test-food A by dissolving it in liquid such as water, at breakfast every day for 4 weeks.

Interventions/Control_2

Ingest test-food B by dissolving it in liquid such as water, at breakfast every day for 4 weeks.

Interventions/Control_3

Ingest test-food C by dissolving it in liquid such as water, at breakfast every day for 4 weeks.

Interventions/Control_4

Ingest test-food D by dissolving it in liquid such as water, at breakfast every day for 4 weeks.

Interventions/Control_5

Ingest test-food E by dissolving it in liquid such as water, at breakfast every day for 4 weeks.

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

60 years-old >

Gender

Female

Key inclusion criteria

1) Person who has a routine visit to Matsuike clinic
"2) Women with mild constipation who are prescribed magnesium oxide at the age of
20 years old or more and under 60 years old
at the time of obtaining informed consent for study participation"
3)Person whose BMI is over 30.0 kg/m^2 or
4)Person who do not take protein-enriched food(protein powder, protein bar, protein drink) during the examination period
5) Person who have be given sufficient explanation about the purpose and contents of this study, has the ability to agree, volunteer for voluntary participation with good understanding, and can consent to this examination in writing
6) Person who can come to Matsuike Clinic on the designated day and receive an interview
7) Person who were considered appropriate to participate in this study by the study doctor

Key exclusion criteria

1) Person who have symptoms other than mild constipation
2) Person who have some factor that the examining physician can not judge the affect to the study
3) Person who have food allergies.
4) Person who regularly drink protein powder (manufacturer is not matter)
5) Person who plan pregnancy, lactation or pregnancy possibility and pregnancy during the study period
6) Person with alcoholism or other mental disorders
7) Person who may change lifestyle during the examination period (night work, long trips, etc.)
8) Person who are planning to take health functional food or supplement food during the test period
9) Person who received treatment with hospitalization within the past 6 months,or who are plannning to be hospitalized during the examination period
10) Person who are currently participating in other clinical trials, or person who have not passed three months after participating in other clinical trials
11) Person who the study doctor judged as inappropriate for this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiroko
Middle name
Last name Uchida

Organization

Morinaga & CO., LTD.

Division name

R & D institute

Zip code

230-8514

Address

2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan

TEL

045-571-2982

Email

h-uchida-ji@morinaga.co.jp


Public contact

Name of contact person

1st name Misae
Middle name
Last name Kawai

Organization

Morinaga & CO., LTD.

Division name

R & D institute

Zip code

230-8514

Address

2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan

TEL

045-571-2982

Homepage URL


Email

m-kawai-ab@morinaga.co.jp


Sponsor or person

Institute

Morinaga & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

Morinaga & 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

Non-Profit Organization MINS Institutional Review Board

Address

5-20-9-401,Mita,Minato-ku,Tokyo,Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.com


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

2022 Year 01 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


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

2022 Year 01 Month 12 Day

Date of IRB

2022 Year 01 Month 13 Day

Anticipated trial start date

2022 Year 01 Month 13 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 12 Day

Last modified on

2022 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name