UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058391 |
|---|---|
| Receipt number | R000066611 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/01 10:21:22 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators
Acronym
A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators
Scientific Title:Acronym
A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the consumption of the test foods on various health indices of the subjects from multiple perspectives.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[Efficacy]
1)Blood health indicators
2)Gut environment
3)Urine health indicators
4)NK cell activity
5)Body composition
6)Bone density
7)AGEs score
8)Face age
9)Survey Surveys
10)Frequency of defecation, stool characteristics
[Safety]
Adverse events and side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 stick per day; 12 weeks).
Interventions/Control_2
Oral intake of the control food (1 stick per day; 12 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals who are between 50 and 75 years of age at the time of obtaining consent to participate in the study.
2) Individuals who wear a pedometer on a daily basis and are able to measure the number of steps taken.
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and who have agreed to participate in the study in writing.
4) Individuals who are able to come to the hospital on the designated examination date and undergo the examination.
Key exclusion criteria
Individuals
1) undergoing treatment for chronic diseases, etc.
2) suffering from or with a history of serious diseases such as malignant tumors, respiratory diseases, liver, kidney, heart, lung, digestive and metabolic systems
3) suffering from or with a history of intestinal diseases.
4) who suffer from or have a history of sleep disorders, psychiatric disorders, drug dependence, or alcohol dependence.
5) with severe anemia.
6) with drug or food allergies or a history of allergies.
7) who regularly use medicines, including laxatives, bowel movements or laxatives.
8) who have taken antibiotics for more than one week within three months.
9)who cannot discontinue food for specified health use, food with functional claims, food with nutrient function claims, supplements, and beverages or foods containing bifidobacteria, lactic acid bacteria, or oligosaccharides during the study period.
10)who have a smoking habit.
11) who consume excessive amounts of alcohol (average of more than 40g/day of pure alcohol per week) and individuals who are unable to abstain from alcohol during the 7days prior to testing.
12) Premenopausal or postmenopausal women within 3years of menopause.
13) Women whose FSH level is less than 40mIU/ml or estradiol level is greater than 20pg/ml.
14)with a Body Mass Index (BMI) of 30kg/m2 or more.
15)with excessive exercise habits.
16) who may change their lifestyle during the study period.
17) who have had blood drawn or donated more than 200mL within 1month of the screening test or 400mL within 3months.
18) who have participated in other drug or food trials within the past month, or who are willing to participate in these trials.
19) who are judged by the investigator to be unsuitable as subjects based on the results of the subject's background, physical examination, physical examination, and clinical examination.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Odamaki |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
R&D Division, Biotics Research Institute
Zip code
252-8583
Address
5-1-83, Higashihara, Zama city, Kanagawa, Japan
TEL
046-252-3000
t-odamak@morinagamilk.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
Morinaga Milk Industry 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 | 07 | Month | 07 | 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 | 05 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066611
