UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061183 |
|---|---|
| Receipt number | R000070016 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on reducing abdominal visceral fat in healthy adult men. |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/07 13:53:28 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on reducing abdominal visceral fat in healthy adult men.
Acronym
A study of the effects of probiotics on reducing abdominal visceral fat in healthy adult men.
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on reducing abdominal visceral fat in healthy adult men.
Scientific Title:Acronym
A study of the effects of probiotics on reducing abdominal visceral fat in healthy adult men.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-obesity effects of continuous probiotic ingestion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
Abdominal subcutaneous fat area, total abdominal fat area, body weight, BMI, waist circumference
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
Intake of test foods for 12 weeks.
Interventions/Control_2
Intake of placebo foods for 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1) Male participants aged 20 to 64 years at the time of obtaining consent.
2) Participants of BMI between 23 kg/m2 and less than 30 kg/m2.
3) Participants who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria
1) Participants with serious diseases (such as cerebrovascular diseases, cardiovascular diseases, liver diseases, gastrointestinal diseases, endocrine and metabolic diseases, or sleep apnea syndrome), or history of these diseases.
2) Participants who regularly take medications that may affect obesity, dyslipidemia, or lipid metabolism.
3) Participants who cannot stop taking health foods or supplements that affect obesity, dyslipidemia or lipid metabolism during the study.
4) Participants who cannot stop consuming foods/supplements containing lactobacilli, bifidobacteria, or oligosaccharides during the study.
5) Participants with a habitual heavy smoking (average of >=21 cigarettes per day).
6) Participants with excessive alcoholic drinks (average daily pure alcohol intake >=60 g).
7) Participants with severe medication or food allergies.
8) Participants with metal in the CT scan measurement site due to surgery, etc.
9) Participants with cardiac pacemakers or implantable cardioverter defibrillators.
10) Participants with claustrophobia that may interfere with CT scanning procedures.
11) Participants judged to have a muscular body type based on their body composition measurements at the screening, as determined by the principal investigator.
12) Participants with a history of digestive tract diseases or digestive tract surgery (except appendicitis).
13) Participants who cannot abstain from alcohol for 2 days before and during evaluation.
14) Participants with a history or current diagnosis of drug dependence or alcohol dependence.
15) Participants with extremely irregular dietary habits, shift workers, or night-shift workers.
16) Participants who have donated >200 mL blood in 1 month, or >400 mL in 3 months before consent.
17) Participants who are currently participating or intend to participate other clinical trials during the study.
18) Participants judged ineligible to this study by principal investigator.
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
Shinagawa Season Terrace 5F, 1-2-70 Konan, Minato-ku, Tokyo
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
| 2026 | Year | 04 | Month | 10 | 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
| 2026 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070016
