UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047852 |
|---|---|
| Receipt number | R000054557 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotics on reducing body fat |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2024/06/20 17:44:15 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotics on reducing body fat
Acronym
Clinical study to evaluate the efficacy of probiotics on reducing body fat
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotics on reducing body fat
Scientific Title:Acronym
Clinical study to evaluate the efficacy of probiotics on reducing body fat
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 probiotics in overweight adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition(abdominal fat, body fat)
Key secondary outcomes
Anthropometry, Serum lipids, Blood glucose-related variables, Liver function, Inflammatory marker
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 ingestion of the test food for 16 weeks
Interventions/Control_2
Oral ingestion of the placebo food for 16 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) Subjects aged more than 20 years, less than 65 years
2) Subjects of BMI between 23 and 30
Key exclusion criteria
1) Subjects who have history of serious disease
2) Subjects who regularly undertake medications that affect obesity, hyperlipidemia or lipid metabolism
3) Subjects who cannot stop taking health foods or supplements that affect obesity, hyperlipidemia or lipid metabolism
4) Heavy smokers
5) Subjects who have excessive alcoholic drinks
6) Subjects with serious medication allergy or food allergy
7) Subjects who have metal in the CT scan measurement site due to surgery, etc.
8) Subjects with cardiac pacemakers or implantable cardioverter defibrillators.
9) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
10) Subjects who are currently participating, or intend to participate during this study period, in other trials involving the testing of other foods or the use of drugs or the application of cosmetics and drugs
11) Subjects who are considered to be inappropriate for this study by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sagami |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshikawa@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
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 Joto-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
| 2022 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10974859/
Number of participants that the trial has enrolled
100
Results
A significant difference was observed in the primary outcome.
(Reference)
Soichiro Sato, Satoshi Arai, Kumiko Kato, Keisuke Yoshida, Noriyuki Iwabuchi, Toru Sagami, Miyuki Tanaka. Effects of Bifidobacterium longum BB536 and Bifidobacterium breve MCC1274 on Body Composition in Normal and Overweight Adults in Randomized Placebo-Controlled Study. Nutrients 16(6): 815 (2024)
Results date posted
| 2024 | Year | 06 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054557
