UMIN-CTR Clinical Trial

Public title

Evaluation of the effects of test food consumption on the number of defecations

Acronym

Evaluation of the effects of test food consumption on the number of defecations

Scientific Title

Evaluation of the effects of test food consumption on the number of defecations

Scientific Title:Acronym

Evaluation of the effects of test food consumption on the number of defecations

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the improvement effect on bowel movements by the consumption of the test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Number of defecations

Key secondary outcomes

Total amount of short-chain fatty acids in feces (sum of acetic acid, propionic acid, and n-butyric acid)
Short chain fatty acids in feces (acetic acid, propionic acid, and n-butyric acid)
Organic acid in feces (lactic acid, succinic acid, iso-valeric acid, n-valeric acid, formic acid, iso-butyric acid)
Ammonia in feces
Fecal putrefactive products (phenol, p-cresol, 4-ethylphenol, skatole, indole)
Water in feces
pH in feces
Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
CAS-MT
Visual Analog Scale (stress, fatigue, the feeling at waking up this morning, concentration)
Gut microbiota

Study type

Interventional

Basic design

Cross-over

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

Consumption of the test food (one a day) for 4 weeks

Interventions/Control_2

Consumption of the placebo food (one a day) for 4 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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Males and females aged 20 to 64 years old.
2. Subjects who defecate less than and equal to 5 times in a week.
3. Subjects who consume wheat flour products such as bread and noodles at least 4 days a week.
4. Subjects who can receive the test food once a week.
5. Subjects who can consume one test food per day.
6. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.

Key exclusion criteria

1. Subjects who take steadily (not less than 2 times a week) in the Food for Specified Health Uses (FOSHU), Foods with Function Claims, health food or supplementary food which might affect the intestinal environment.
* However, subjects who consume the above-mentioned food products once a week or less, but cannot discontinue them from the time of obtaining consent, are not eligible to participate.
2. Subjects who consume yogurt, lactic acid bacteria beverages, and high-fiber staple foods (such as brown rice, barley, whole wheat bread, cereals, and foods with nutrient fortification claims) that are not classified as Food for Specified Health Uses (FOSHU) or Foods with Function Claims, three or more times a week.
3. Subjects who have had one or more days per week with less than one meal per day in the month leading up to the preliminary examination.
4. Subjects who are on a carbohydrate-restricted diet or are dieting.
5. Subjects with excessive alcohol intake.
6. Subjects with extremely irregular lifestyles (such as night shifts, irregular shift work, etc.).
7. Subjects with a BMI of 30.0 kg/m2 or above.
8. Subjects who plan to change their lifestyle, dietary habits, or living environment (such as moving or job transfer) during the trial period.
9. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
10 Subjects who have a cohabitant planning to participate in this trial.
11. Subjects with a history of appendectomy.
12. Subjects who have undergone surgery that is considered to affect the trial within six months prior to obtaining consent (e.g., colonoscopic surgery, gallstone/gallbladder removal, gastric bypass surgery, etc.).
13. Subjects who have taken medications affecting the intestinal environment (such as antibiotics, probiotics, laxatives, etc.) one month prior to Week 0 of Phase 1, or who plan to do so during the trial period.

Target sample size

46

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Ichinohe

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Nisshin Seifun Group Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.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

2024

Year

10

Month

18

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

2023

Year

09

Month

25

Day

Date of IRB

2023

Year

09

Month

22

Day

Anticipated trial start date

2023

Year

10

Month

20

Day

Last follow-up date

2024

Year

02

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
14. Subjects undergoing medication therapy or dietary therapy.
15. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
16. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
17. Subjects with allergies to medications and food (especially wheat, eggs, milk, soy).
18. Subjects who donated blood or component (200 mL) within the last 1 months.
19. Subjects who donated his blood (400 mL) within the last 3 months.
20. Subjects who donated her blood (400 mL) within the last 4 months.
21. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research.
22. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research.
23. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Registered date

2023

Year

10

Month

19

Day

Last modified on

2024

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059772