UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058027 |
|---|---|
| Receipt number | R000065968 |
| Scientific Title | Test to verify the effects of test food intake on bowel movements and improvement of the intestinal environment, and to examine the effects on sleep, stress, and fatigue |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/02 17:40:16 |
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Basic information
Public title
Test to verify the effects of test food intake on bowel movements and improvement of the intestinal environment, and to examine the effects on sleep, stress, and fatigue
Acronym
Test to verify the effects of test food intake on bowel movements and improvement of the intestinal environment, and to examine the effects on sleep, stress, and fatigue
Scientific Title
Test to verify the effects of test food intake on bowel movements and improvement of the intestinal environment, and to examine the effects on sleep, stress, and fatigue
Scientific Title:Acronym
Test to verify the effects of test food intake on bowel movements and improvement of the intestinal environment, and to examine the effects on sleep, stress, and fatigue
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of the test food on bowel movements, improvement of the intestinal environment, and to evaluate the effects on sleep, stress, and fatigue after four consecutive weeks of consumption of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diary of bowel movements
(Daily from before ingestion to the end of the study)
Key secondary outcomes
*Secondary Endpoints
Diary of bowel movements (1)
Intestinal microflora analysis (2)
Fecal organic acid analysis (2)
Blood special tests (2)
Sleep related indicators (2)
Stress related indicators (2)
Fatigue related indicators (2)
*Safety endpoints
Physical examination (2)
Clinical examination (2)
Doctor's questions (2)
Determination of adverse events and side effects (2)
Subject's diary (1)
(1):Daily from before ingestion to the end of the study
(2):Week 0, Week 4
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 capsule in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule in a day; 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 64 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals with relatively hard stools and suffering from mild constipation.
4) Individuals with spontaneous defecation frequency of 3-4 times per week.
5) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
1) with chronic illnesses and individuals undergoing treatment for any illness.
2) with a history or current history of chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
3) with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract.
4) with serious anemia.
5) with a habit of taking or applying drugs for the purpose of disease treatment in the past month.
6) who have been diagnosed and are being treated for functional constipation at a medical institution.
7) who are determined to have chronic constipation according to the diagnostic criteria of the Guidelines for the Diagnosis of Bowel Movement Disorders 2023.
8) whose BMI is over 30 kg/m2.
9) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
10) who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period.
11) who have a habit of consuming yogurt, fermented foods rich in lactic acid bacteria, etc. at least 5 days per week.
12) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent.
13) who are a smoker.
14) with irregular lifestyles, such as shift work, night work, etc.
15) with possible changes of life style during the test period.
16) who have had more than 200 mL of blood drawn within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study.
17) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
18) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period.
19) judged inappropriate for the study by the principal.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Tanaka |
Organization
Nicorio Co., Ltd.
Division name
Research & Development
Zip code
154-0004
Address
17F Carrot Tower, 4-1-1 Taishido, Setagaya-ku, Tokyo
TEL
03-6431-8830
yuji.tanaka@nicorio.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nicorio 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2025 | Year | 05 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065968
