UMIN-CTR Clinical Trial

Public title

Verification of the effects of test foods on the intestinal environment

Acronym

Verification of the effects of test foods on the intestinal environment

Scientific Title

Verification of the effects of test foods on the intestinal environment

Scientific Title:Acronym

Verification of the effects of test foods on the intestinal environment

Region

Japan

Asia(except Japan)

Condition

None

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To obtain data on the improvement of the intestinal environment through the consumption of the test food for 4 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Bifidobacteria, good bacteria

Key secondary outcomes

Other intestinal environment data

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of test food (4 weeks)

Interventions/Control_2

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

60

years-old

>

Gender

Male

Key inclusion criteria

1) Healthy Japanese males whose age is between 20 and 60 years old.
2) No gastrointestinal disease. 2) No gastrointestinal disease, and not taking any medication during treatment.
3) BMI between 20 kg/m2 and 30 kg/m2.
4) Subjects who are aware that their intestinal environment is not good, such as constipation.
5) The subjects must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.

Key exclusion criteria

1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease
2) Persons who are currently undergoing treatment for a serious illness.
3) Persons with food allergies or those who are at risk of developing allergies related to the tested food
4) Who are regularly using medicines or quasi-drugs that may affect the test items.
5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items.
6) Persons who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study.
7) Persons who are unable to restrict or discontinue foods (including alcohol) that affect the data
8) Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent
9) Who plan to participate in other clinical trials during the study period
10) Who are unable to maintain their daily lifestyle.
11) Who have difficulty consuming the study food as directed
12) Other subjects who are judged by the investigator to be unsuitable for the study.

Target sample size

20

Name of lead principal investigator

1st name	Ikuko
Middle name
Last name	Sagara

Organization

Well Aging Medical Corporation D Clinic Tokyo Wellness

Division name

department of internal medicine

Zip code

100-0005

Address

1-11-1 Marunouchi, Chiyoda-ku, Tokyo Pacific Century Place Marunouchi 10F

TEL

03-6665-0502

Email

plantanikuko@gmail.com

Name of contact person

1st name	Masako
Middle name
Last name	Mizuuchi

Organization

APO PLUS STATION CO., LTD.

Division name

Clinical Operations Department, CRO Division

Zip code

103-0027

Address

2-14-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan

TEL

03-6386-8809

Homepage URL

Email

food-contact@apoplus.co.jp

Institute

APO PLUS STATION CO., LTD.

Institute

Department

Personal name

Organization

ANGFA Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic

Address

1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japan

Tel

03-6661-9061

Email

c-irb_ug@neues.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

05

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

2022

Year

04

Month

26

Day

Date of IRB

2022

Year

04

Month

26

Day

Anticipated trial start date

2022

Year

05

Month

13

Day

Last follow-up date

2022

Year

07

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

05

Month

12

Day

Last modified on

2022

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054425