UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031266
Receipt number R000035698
Scientific Title Pre-examination: Effect of dietary Mozuku powder on gut microbiota composition.
Date of disclosure of the study information 2018/02/15
Last modified on 2018/06/13 09:51:03

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Basic information

Public title

Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.

Acronym

Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.

Scientific Title

Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.

Scientific Title:Acronym

Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.

Region

Japan


Condition

Condition

Because it is a test for healthy subjects, there is no target disease.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Dietary fiber is metabolized by intestinal fermentation of more than 100 trillion bacteria present in the intestinal tract without being decomposed by the digestive juice at the upper part of the gastrointestinal tract, and is converted into a useful metabolite for the health of the host. In addition to being used as an energy source in intestinal mucosa, this metabolite is known to inhibit proliferation of intestinal putrefactive bacteria, etc., to prepare intestinal environment, promote peristaltic movement of intestine, and promote defecation.
Okinawa virgin soybean is a food with a high content of dietary fiber, and an effect of improving the number of times of defecation by reporting that 2.4 g of dry powder is taken a day is reported. However, since there is no report on intestinal bacterial flora analysis due to ingestion of this powder, a comparative test between the test food intake group containing the dry powder of Okinawawa mozuku and the control test food intake group was planned and the intestinal flora By analysis, Bifidobacterium occupancy ratio to total number of bacteria is determined, and the intestinal action of Okinawan mozuku derived dietary fiber is examined.

Basic objectives2

Others

Basic objectives -Others

usefulness

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The ratio of Bifidobacterium to the number of intestinal inner layer bacteria

Key secondary outcomes

Defecation status


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

Dry mozuku powder blending sprinkle

Interventions/Control_2

Dry mozuku powder non-blended sprinkle

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 people who do not have severe disease

2. A person who wishes voluntarily to participate in clinical trials in men and women aged 20 years or over and under 65 years old and who can obtain written informed consent

3.Those who can withdraw laxatives, constipation drugs, supplements expected to have bowel improvement effect, health tea etc during the examination period.

4. people with constipation tendency (stool frequency ~ 3 times / week, excluding severe constipation)

5. Those who do not take supplements that are predicted to constantly improve constipation medicine and bowel movement within the first month

6. Who can keep daily lifestyle habits constant during the examination period

7. Study participation of people who are treating mild chronic diseases (hypertension, hyperlipemia, etc.) shall be able to participate at the discretion of the investigator

Key exclusion criteria

1. People with severe diseases (heart disease, liver disease, kidney disease, cancer, etc.) and mental illness.

2. People with digestive system disease history and surgery history of digestive organs.

3. constipation who may be caused by diseases (colorectal cancer, Crohn's disease, etc.) and drugs (anticholinergics, antidepressants, etc.)

4. Those who can not maintain everyday life habits with large changes in diet and exercise.

5. If you work on shifts, work at midnight.]

6. Persons who constantly take on laxatives, constipation medicine and supplements, health tea etc. expected to improve bowel movement regularly or within 1 month of the month within 1 month.

7. Possible food allergy and drug allergy to the test food.

8. Pregnant women / lactating women and those who wish pregnant during the examination period.

9. Others who have made the examination responsible doctor ineligible for participation in this exam.

10. Those who participate in other clinical trials within the past month.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ono, Seiichi

Organization

Wellbe Inc.

Division name

Clinical Research Division

Zip code


Address

Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan

TEL

098-988-9007

Email

abe@well-b.jp


Public contact

Name of contact person

1st name
Middle name
Last name Abe, Hiroyuki

Organization

Wellbe Inc.

Division name

Clinical Research Division

Zip code


Address

Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan

TEL

098-988-9007

Homepage URL


Email

abe@well-b.jp


Sponsor or person

Institute

Wellbe Inc.

Institute

Department

Personal name



Funding Source

Organization

Okinawa Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 02 Month 15 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

No longer recruiting

Date of protocol fixation

2018 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 03 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2018 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name