UMIN-CTR Clinical Trial

Public title

Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial

Acronym

Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial

Scientific Title

Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial

Scientific Title:Acronym

Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To investigate the effects of continuous consumption of dietary ingredient on bowel movements and the intestinal environment in healthy adult men and women aged 20 to less than 70 years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation frequency and number of days with defecation

Key secondary outcomes

(Secondary outcomes)
Gut microbiota, Bowel habits(stool volume, stool consistency,stool color, stool odor, stool smell, and post-defecation sensation), VAS assessment of abdominal symptoms, POMS 2-A short, fecal short-chain fatty acid (SCFA) concentrations, fecal bile acid concentrations, fecal metabolites, in vitro fecal culture assay using stool samples,association analysis between evaluation parameters and single nucleotide polymorphisms (SNPs)
(Safety evaluation)
Vital signs, physical measurements (body weight and BMI), blood biochemical examination, hematologic test, adverse events

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Continuous ingestion of the test food 1 for 4 weeks

Interventions/Control_2

Continuous ingestion of the test food 2 for 4 weeks

Interventions/Control_3

Continuous ingestion of the placebo food for 4 weeks

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

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Healthy Japanese males and females who are aged 20 to under 70 years at the time of written informed consent.
2.Subjects who defecate three to five times per week at screening period.
3.Subjects whose BMI is less than 30 kg/m2.
4.Subjects who have regular eating habits every day and are able to generally eat three meals a day during the study.
5.Subjects who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.

Key exclusion criteria

1.Subjects diagnosed with constipated by a physician or have diseases that may substantially affect bowel movement.
2.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
3.Subjects receiving medication or outpatient treatment for a serious disease.
4.Subjects receiving exercise or diet therapy under the supervision of a physician.
5.Subjects with current or previous history of drug dependence or alcohol dependence.
6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
7.Subjects who are taking antibiotics or other medications that affect the gut microbiome or who plan to take these during the study.
8.Subjects who regularly use bowel-regulating drugs (including traditional Chinese medicines), quasi-drugs (e.g., probiotics, constipation medicines including laxatives), health foods, or supplements or who cannot avoid using them.
9.Subjects who were consuming health oils (e.g., coconut oil, MCT oil) that may increase the effects of the food components to be evaluated 4 days or more each week during the past three months or who are consuming such oils.
10.Subjects who are consuming foods rich in components that may affect bowel movements, or foods rich in components that may affect the research area (e.g., yogurt, lactic acid bacteria beverages, fiber- or oligosaccharide-enriched foods, milk, butter, ice cream, cheese, foods rich in milk fat, other fermented foods, granola, prunes) 4 days or more each week.
11.Subjects who are at risk of developing allergic reactions due to the ingredients of the test food's or other factors.
12.Night or shift workers with irregular life patterns.

Target sample size

150

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Miyazawa

Organization

HUMA R&D CORP

Division name

Clinical Development Department

Zip code

108-0023

Address

NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan

TEL

03-3431-1260

Email

rd@huma-rd.co.jp

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Miyazawa

Organization

HUMA R&D CORP

Division name

Clinical Development Department

Zip code

108-0023

Address

NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan

TEL

03-3431-1260

Homepage URL

Email

rd@huma-rd.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

The Nisshin OilliO Group, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Shinjuku Clinic Ethical Review Board

Address

5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan

Tel

03-6709-6071

Email

tokyoshinjuku@taifukukai.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

2025

Year

08

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

Preinitiation

Date of protocol fixation

2025

Year

07

Month

09

Day

Date of IRB

2025

Year

07

Month

11

Day

Anticipated trial start date

2025

Year

08

Month

19

Day

Last follow-up date

2025

Year

12

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
13.Subjects doing physical work for 10 hours or more per week.
14.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week.
15.Smoking subjects or those who have stopped smoking within 1 years before the date of informed consent.
16.Heavy users of alcohol (the mean consumption of average weekly pure alcohol is 30 g/day or more).
17.Subjects whose eating, sleeping, and other habits are extremely irregular.
18.Subjects who are having a very unbalanced diet.
19.Subjects who sometimes substitute sweets or nutritional jellies for meals.
20.Subjects who plan to change their exercise lifestyle, lifestyle or eating habits during the study.
21.Subjects whose body weight increased or decreased by 5 kg or more in the last 2 months.
22.Subjects anticipating a significant change in the family or work environment or stressful circumstances (e.g., job change, moving house, marriage, infant feeding, nursing care, having a co-resident family member who will be taking a school/university entrance examination soon, going out on an unusual occasion involving an overnight stay) during the study.
23.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
24.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
25.Female who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
26.Subjects who have difficulty complying with recording of each survey form.
27.Subjects whose laboratory test values or various test results at screening indicate their ineligibility to participate in the study.
28.Other Subjects who are considered ineligible for participation in the study by the investigator.

Registered date

2025

Year

08

Month

18

Day

Last modified on

2025

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067077