UMIN-CTR Clinical Trial

Public title

The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial

Acronym

The verification study for improving the intestinal environment

Scientific Title

The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial

Scientific Title:Acronym

The verification study for improving the intestinal environment

Region

Japan

Condition

Healthy Japanese adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of the test food on defecation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

1. Bowel movement diary
2. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*¹ Keep it from a week before screening test and a week before consuming to 4 weeks after consuming
*² Assess at 0 and 4 weeks after consuming

Key secondary outcomes

1. Bacterial flora analysis (T-RFLP)
2. Bristol scale
*^1,2 Assess at 0 and 4 weeks after consuming

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test materials: Konjac processed food
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.

Interventions/Control_2

Duration: 4 weeks
Test materials: Konjac processed food
Dose: 2 packs a day (1 pack for once)
Administration: Take 1 pack in the morning and evening. If you take either breakfast or dinner, take the test food 15 minutes before the meal.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.

Interventions/Control_3

Duration: 4 weeks
Test materials: Placebo
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adults

2. Those who defecate three to five times per week

3. Those who are considered as appropriate for the study by the physician

4. Among the people who passed 3., 3 or more male and 3 or more female are selected from each generation (20s, 30s, 40s, 50s, and 60s). (e.g., 6 or more people are selected from each generation.)

5. Among the people who passed 4., those who have relatively few defecation frequency during a week before screening and advance examination

6. Among the people who passed 5., those who have relatively high score in the Japanese version of Constipation Assessment Scale MT version (CAS-MT)

Key exclusion criteria

1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines and/or herbal medicines

5. Those who are allergic to medicines, milk, beans, orange, and/or other food products

6. Those who are pregnant, breast-feeding, and plan to become a pregnant

7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

8. Others considered as inappropriate for the study by the physician

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

ORIHIRO Plantdew Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Date of disclosure of the study information

2017

Year

06

Month

20

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/47090/1445

Number of participants that the trial has enrolled

33

Results

Gokan N, Hoshino T, Takara T. Improvement of the Intestinal Environment by Konjac Processed Food-A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparison Trial-. Jpn Pharmacol Ther. 2019; 47(9): 1445-1454

Results date posted

2021

Year

05

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2019

Year

10

Month

02

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

19

Day

Date of IRB

Anticipated trial start date

2017

Year

06

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

20

Day

Last modified on

2021

Year

05

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031887