UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040039
Receipt number 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 2021/04/05 08:07:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.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