UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Plant-Derived Products on gut microbiome -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Plant-Derived Products on gut microbiome
Scientific Title	A Study on the Effect of Plant-Derived Products on gut microbiome -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Plant-Derived Products on gut microbiome
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of plant-derived products on gut microbiome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gut microbiome
Key secondary outcomes	Defecation questionnaire, Conditioning questionnaire

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Plant-Derived Products, 4 weeks consumption
Interventions/Control_2	Placebo Products, 4 weeks consumption
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy males and females aged 20 to 64 years-old who defecate three to five a week. (2)Subjects who do not habitually consume a large amounts of alcohol. (3)Subjects who regularly eat three meals a day. (4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	Subjects (who) (1)regularly use intestinal and constipation drugs (including laxatives). (2)can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses or Foods with Function Claims) and/or containing a large amount of sugar alcohol during this study. (3)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation. (4)used antibiotics within the last 2 weeks prior to the screening. (5)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (6)have been diagnosed irritable bowel syndrome or inflammatory bowel disease. (7)have any food allergies. (8)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 4 days a week. (9)can't stop drinking from 2 days before each measurement. (10)are shiftworker and/or midnight-shift worker. (11)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (12)with greatly disturbed menstrual cycle. (13)plan to become pregnant after informed consent, pregnant or lactating. (14)have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the study. (15)are under treatment for or have a history of drug addiction and/or alcoholism. (16)plan to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month. (17)are judged unsuitable for the study by the screening. (18)are judged unsuitable for the study by the investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU 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	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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 22 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049087
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49100/1681
Number of participants that the trial has enrolled	60
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2021 Year 12 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 20 to 64 years old.
Participant flow	Enrolled(n=60) Completed(n=60) Analysed(n=55)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	gut microbiome
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 12 Month 08 Day
Date of IRB	2020 Year 12 Month 14 Day
Anticipated trial start date	2021 Year 01 Month 23 Day
Last follow-up date	2021 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 15 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049087