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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046615
Receipt No. 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 2022/01/12

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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
Institute Morinaga & CO., LTD.
Institute
Department

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 Preinitiation
Date of protocol fixation
2022 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 13 Day
Last follow-up date
2022 Year 05 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 01 Month 12 Day


Link to view the page
URL(English) 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


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