UMIN-CTR Clinical Trial

Public title

Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect

Acronym

Enteral environment improvement effect of foods believed to have such an effect

Scientific Title

Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect

Scientific Title:Acronym

Enteral environment improvement effect of foods believed to have such an effect

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective was to evaluate the effect on bowel movements by consuming foods believed to improve the enteral environment on bowel movements.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation frequency, defecation quantity, stool form, stool hardness, stool color, stool odor, and post-defecation feeling

Key secondary outcomes

1. Fecal flora (Lactobacillus, Bifidobacterium)
2. Anti-metabolic syndrome effect (LDL cholesterol, triglycerides, HDL cholesterol, fasting blood sugar, insulin, HbA1c)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects consume two pieces of food believed to improve the enteral environment daily for 12 weeks.

Interventions/Control_2

Subjects consume two pieces of a placebo food daily for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Those who receive an appropriate explanation of the purpose and content of the study, are able to consent, voluntarily request to participate after gaining a full understanding, and are able to consent to participation in this survey in writing.
2. Healthy individuals with a defecation frequency of 2 to 5 times per week, inclusive.

Key exclusion criteria

Individuals meeting any of the following conditions will not be selected as study subjects:
1. Pregnant and nursing mothers, and individuals with a desire to become pregnant during the study period
2. Individuals taking medication on a routine basis
3. Individuals who are taking foods for specific health use, foods with function claims, and/or health foods, in the case that such foods affect gastrointestinal function
4. Individuals with persistent diarrhea.
5. Individuals with a fruit allergy
6. Individuals whose fasting blood test results during a physical examination include: blood glucose >=126 mg/dL, LDL cholesterol >=140 mg/dL, triglycerides >=150 mg/dL, or HDL cholesterol <40 mg/dL
7. Other individuals deemed unsuitable by the principal investigator.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Shunji Mizobuchi

Organization

Kochi Medical School, Kochi University

Division name

Clinical nursing

Zip code

Address

Kohasu, Oko-cho, Nankoku-city, Kochi, Japan

TEL

088-866-5811

Email

mizoshun@kochi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shunji Mizobuchi

Organization

Kochi Medical School, Kochi University

Division name

Clinical nursing

Zip code

Address

Kohasu, Oko-cho, Nankoku-city, Kochi, Japan

TEL

088-880-2564

Homepage URL

Email

mizoshun@kochi-u.ac.jp

Institute

Kochi University

Institute

Department

Personal name

Organization

Public Interest Incorporated Foundation
KOCHI INDUSTRIAL PROMOTION CENTER

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

高知大学医学部（高知県）、高知大学医学部附属病院（高知県）、医療法人 仁泉会 朝倉病院（高知県）、医療法人 浦松会 南国厚生病院（高知県）

Date of disclosure of the study information

2018

Year

03

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

28

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

08

Day

Last modified on

2018

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036131