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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041442
Receipt No. R000047306
Scientific Title A study of the effects of food containing dietary fiber on intestinal flora
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/17

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Basic information
Public title A study of the effects of food containing dietary fiber on intestinal flora
Acronym A study of the effects of food containing dietary fiber on intestinal flora
Scientific Title A study of the effects of food containing dietary fiber on intestinal flora
Scientific Title:Acronym A study of the effects of food containing dietary fiber on intestinal flora
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of legume based foods on diversity of intestinal flora and bowel movements
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diversity of intestinal flora
(Changes in species-level composition ratios)
Key secondary outcomes ・Intestinal metabolites
・Saliva secretory IgA
・defecation frequency
・Questionnaire about physical condition
and mental status
・the change of body weight


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Control foods(14 times ingestion)-Test foods (28 times ingestion)-Control foods(28 times ingestion)
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
50 years-old >
Gender Female
Key inclusion criteria (1) Healthy females aged between 20 and 50.
(2) Defecation frequency 3 to 5 times a week
(3) BMI 23.0 or more and less than 25.0
(4) Those who answered that they felt anxious about their physical condition in the questionnaire survey
(5) Those who answered that they felt stressed in the questionnaire survey
(6) Those who had a cold or flu once within a year
Key exclusion criteria (1) Those who participated in other clinical trials within 1 month
(2) Those who have taken drugs such as antibiotics that affect the intestinal flora, or those who have taken them within one month
(3) Those who cannot stop the additional intake foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, foods reinforced with oligosaccharides and dietary fiber, health foods (including special health foods) that are considered to be effective in improving constipation, supplements, and pharmaceutical products during the test period (Excludes those taken before the start of the test)
(4) Those who have a disease that requires urgent treatment or who have serious complications
(5) Those who have a history of gastrointestinal disorders that affect digestive absorption and defecation, or have a history of surgery for them
(6) Those who take medicines that have constipation as a side effect
(7) Those who are judged to be inappropriate as a subject from the answers to the subject background questionnaire
(8) Those who are participating or willing to participate in the clinical test of ingesting other foods or using drugs, the test of applying cosmetics and drugs and so on
(9) Those who have a history of drug dependence or alcohol dependence or current medical history of them
(10) Those who are pregnant, planning to become pregnant, or breastfeeding
(11) Those who have some food allergies
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Taguchi
Organization Unlog K.K.
Division name CEO
Zip code 151-0053
Address 107 New State Menor, 2-23-1, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL 03-6276-5587
Email tagc@unlog.co.jp

Public contact
Name of contact person
1st name Joto
Middle name
Last name Yoshimoto
Organization Mizkan Holdings Co., Ltd.
Division name Central Research Institute
Zip code 475-8585
Address 2-6 Nakamura-Cho, Handa-Shi, Aichi, Japan
TEL 0569-24-5139
Homepage URL
Email yoshimoto_jyoutou@mizkan.co.jp

Sponsor
Institute Unlog K.K.
Institute
Department

Funding Source
Organization Mizkan Holdings 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 Unlog K.K.
Address 107 New State Menor, 2-23-1, Yoyogi, Shibuya-ku, Tokyo, Japan
Tel 03-6276-5587
Email mail@unlog.co.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
2020 Year 09 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
2020 Year 07 Month 17 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 02 Month 28 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 08 Month 17 Day
Last modified on
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047306

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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