UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058205 |
|---|---|
| Receipt number | R000066521 |
| Scientific Title | A study to evaluate the effectiveness of foods containing lactic acid bacteria in reducing obesity in healthy participants(including a long-term safety assessment) |
| Date of disclosure of the study information | 2025/06/17 |
| Last modified on | 2025/08/12 09:59:40 |
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Basic information
Public title
A study to evaluate the effectiveness of foods containing lactic acid bacteria in reducing obesity in healthy participants(including a long-term safety assessment)
Acronym
A study to evaluate the effectiveness of foods containing lactic acid bacteria in reducing obesity in healthy participants(including a long-term safety assessment)
Scientific Title
A study to evaluate the effectiveness of foods containing lactic acid bacteria in reducing obesity in healthy participants(including a long-term safety assessment)
Scientific Title:Acronym
A study to evaluate the effectiveness of foods containing lactic acid bacteria in reducing obesity in healthy participants(including a long-term safety assessment)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of consuming foods containing lactic acid bacteria for 12 consecutive weeks on visceral fat area
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
1) Total fat area
2) Subcutaneous fat area
3) Body weight
4) BMI
5) Body fat mass
6) Body fat percentage
7) Waist circumference
8) Hip circumference
9) Triglycerides
10) Total cholesterol
11) LDL-cholesterol
12) HDL-cholesterol
13) SNAQ-JE
14) GLP-1
15) Insulin
16) Glucose
17) HOMA-IR
18) Satiety VAS
19) BITE(Binge Eating Illness Self Evaluation Scale)
20) Relative abundance of gut microbiota at the phylum and family levels
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
Ingestion of the test food for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo (control food) for 12 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged between 20 and 64 years,inclusive,at the time of informed consent.
2) participants with high-normal BMI (>=23 and <25) or class I obesity (>=25 and <30), measured in kg/m^2.
3) participants who are aware of their tendency to overeat but have been assessed as healthy by a physician.
4) participants who have received a full explanation of the purpose and procedures of the study and have signed the informed consent form prior to study initiation.
Key exclusion criteria
1) Participants who consume health foods, FOSHU, or functional foods containing lactobacilli or bifidobacteria at least once a week
2) Participants who regularly consume, at least weekly, products (medicines, health foods, FOSHU, or functional foods) with ingredients affecting glucose metabolism or appetite
3) Participants who engage in excessive regular physical exercise
4) Participants who skip meals at least once a week
5) Participants who habitually consume over 20g of pure alcohol daily
6) Participants who consume lactobacillus-rich foods (e.g., fermented milk drinks, yogurt, kimchi) or supplements at least twice a week
7) Participants diagnosed with binge eating disorder based on the BITE
8) Participants with serious conditions (e.g., diabetes, liver, kidney, or heart disease) or relevant medical history
9) Participants currently under treatment or with a history of serious illness requiring pharmacological intervention
10) Participants at risk of allergic reactions to the study intervention
11) Participants who donated 200/400 mL of blood or received a transfusion within 3 months before screening
12) Participants deemed unsuitable based on screening lab results or physical measurements
13) Participants who joined another clinical trial within 1 month before consent or plan to during the study
14) Participants diagnosed with chronic constipation
15) Participants who are pregnant, breastfeeding, or planning to during the study
16) Participants who are otherwise deemed unsuitable for participation in the study by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Fukao |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu-shi, Saitama, 348-8549, Japan
TEL
048-565-4686
masanori.fukao@nissin.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Gokammachi, Maebashi-Shi, Gumma, 371-0813, Japan
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
医療法人 前橋北病院 / Maebashi North Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066521
