UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048679
Receipt number R000055470
Scientific Title Investigation of the effect of test food on the intestinal barrier
Date of disclosure of the study information 2023/04/01
Last modified on 2023/06/05 12:45:13

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Basic information

Public title

Investigation of the effect of test food on the intestinal barrier

Acronym

Investigation of the effect of test food on the intestinal barrier

Scientific Title

Investigation of the effect of test food on the intestinal barrier

Scientific Title:Acronym

Investigation of the effect of test food on the intestinal barrier

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of the test food consumed for 8 weeks on intestinal barrier index

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intestinal barrier index

Key secondary outcomes

Blood/fecal tests
Subjective symptoms


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 8 weeks

Interventions/Control_2

Control (No treatment)

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1. Males and females aged more than or equal to 20, and less than 75 when obtaining the consent
2. Subjects whose BMI is 18.5 or more and less than 30
3. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent

Key exclusion criteria

1. Subjects who have been reported to have galactosemia
2. Subjects who have history of gastrointestinal surgical procedures
3. Subjects who take food or supplement which have the possibility to affect the results of the present study more than 4 days a week before 2 months of informed consent
4. Subjects who can't restrict food or supplement which have the possibility to affect the results of the present study from the observation period to the present study period
5. Subjects who take medications that may affect bowel symptoms or non-steroidal anti-inflammatory drugs such as aspirin more than 3 days a week before 1 months of informed consent
6. Subjects who have taken antibiotics before 2 months of informed consent
7. Subjects who can't restrict taking OTC drugs, quasi-drugs, supplements, or health foods from the day before the examination until the completion of the examination
8. Subjects who are expected to undergo a major change in their home, work, or other living environment during the research period
9. Subjects who are smokers
10. Subjects who have abdominal symptoms by ingesting dairy products
11. Subjects with food allergies
12. Subjects who are pregnant or lactating, or intending to become pregnant during the study
13. Subjects who had participated in other clinical trials within the past month
14. Subjects suffering from or undergoing treatment for diabetes, digestive diseases, heart disease, thyroid disease, adrenal disease, and other metabolic diseases
15. Subjects who tested positive for hepatitis B virus or hepatitis C virus in the screening
16. Subjects deemed unsuitable for the present study by the investigator

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 Eiji
Middle name
Last name Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

eigyou27@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Meiji 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 Kobuna Orthopedics Clinic

Address

5-656-17 Joutou-machi, Maebashi-shi, Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.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

2023 Year 04 Month 01 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

Completed

Date of protocol fixation

2022 Year 06 Month 08 Day

Date of IRB

2022 Year 06 Month 09 Day

Anticipated trial start date

2022 Year 08 Month 27 Day

Last follow-up date

2023 Year 05 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

2022 Year 08 Month 16 Day

Last modified on

2023 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055470


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name