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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040039
Receipt No. R000045650
Scientific Title Changes in gut microbiome and verification of effective dose by test food intake -Randomized double-blind parallel group comparison method-
Date of disclosure of the study information 2020/04/10
Last modified on 2020/08/05

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Basic information
Public title Changes in gut microbiome and verification of effective dose by test food intake
Acronym Changes in gut microbiome and verification of effective dose by test food intake
Scientific Title Changes in gut microbiome and verification of effective dose by test food intake
-Randomized double-blind parallel group comparison method-
Scientific Title:Acronym Changes in gut microbiome and verification of effective dose by test food intake
-Randomized double-blind parallel group comparison method-
Region
Japan

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

Objectives
Narrative objectives1 This study examines the effects of test food intake on the changes in gut microbiome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composition ratio of gut microbiome
Key secondary outcomes -Defecation status
-Gastrointestinal condition and appetite
-Mood status
-Skin condition and sleep quality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 10
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of the low dose of prebiotics material + polymer material dose1, once a day for 2 weeks
Interventions/Control_2 Intake of the low dose of prebiotics material + polymer material dose2, once a day for 2 weeks
Interventions/Control_3 Intake of the low dose of prebiotics material + polymer material dose3, once a day for 2 weeks
Interventions/Control_4 Intake of the low dose of prebiotics material + polymer material dose4, once a day for 2 weeks
Interventions/Control_5 Intake of the low dose of prebiotics material + polymer material dose5, once a day for 2 weeks
Interventions/Control_6 Intake of the high dose of prebiotics material + polymer material dose1, once a day for 2 weeks
Interventions/Control_7 Intake of the high dose of prebiotics material + polymer material dose2, once a day for 2 weeks
Interventions/Control_8 Intake of the high dose of prebiotics material + polymer material dose3, once a day for 2 weeks
Interventions/Control_9 Intake of the high dose of prebiotics material + polymer material dose4, once a day for 2 weeks
Interventions/Control_10 Intake of the high dose of prebiotics material + polymer material dose5, once a day for 2 weeks

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria (1)Japanese healthy male and female aged 20-60 years whose defecation frequency is 3-5 times a week
(2)Subjects who have low-level Bifidobacterium at the point of screening
(3)Subjects who usually take three meals a day
(4)Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document
Key exclusion criteria (1)Subjects who usually take intestinal drugs and laxatives
(2)Subjects who cannot stop the consumption of healthy foods which may have good effect on constipation during the test period
(3)Subjects who usually take healthy supplements
(4)Subjects who cannot stop the consumption of foods which are containing lactic acid bacteria, bifidobacteria, oligosaccharides, and natto bacteria (probiotics and prebiotics materials )
(5)Subjects who have gastrointestinal disorders or a surgical history and who usually take gastrointestinal drugs
(6)Subjects who have been diagnosed irritable bowel syndrome or inflammatory bowel disease
(7)Subjects who have liver disease, kidney disease and diabetes mellitus
(8)Subjects who have allergic to food
(9)Subjects who have pollinosis and take drugs which affects gut microbiome
(10)Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period
(11)Subjects who participate in other clinical trials (food, pharmaceuticals and cosmetics), who have participated in other tests within one month of obtaining consent, or who are willing to participate
(12)Subjects who are judged as unsuitable for the study by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Mine
Organization Ajinomoto Co., Inc.
Division name Institute of Food Sciences and Technologies
Zip code 2108681
Address 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL 044-223-4114
Email tomoyuki_mine@ajinomoto.com

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Umeda
Organization Ajinomoto Co., Inc.
Division name Institute of Food Sciences and Technologies
Zip code 2108681
Address 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL 044-223-4114
Homepage URL
Email kentaro_umeda@ajinomoto.com

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Ajinomoto Co., Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor KSO Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of Nihonbashi Cardiology Clinic
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel 03-5641-4133
Email niho-jimucho@well-sleep.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 医療法人財団健康睡眠会 日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 10 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 02 Month 19 Day
Date of IRB
2020 Year 06 Month 25 Day
Anticipated trial start date
2020 Year 08 Month 15 Day
Last follow-up date
2021 Year 01 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
2020 Year 04 Month 03 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045650

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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