UMIN-CTR Clinical Trial

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	100
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	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	2021 Year 04 Month 05 Day

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