UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043006
Receipt number R000049087
Scientific Title A Study on the Effect of Plant-Derived Products on gut microbiome -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2021/01/22
Last modified on 2021/12/24 15:56:34

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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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name