UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049328 |
|---|---|
| Receipt number | R000056177 |
| Scientific Title | A confirmation study for effects of synbiotics on reducing body fat: A randomized, double-blind, placebo-controlled parallel group study |
| Date of disclosure of the study information | 2024/01/13 |
| Last modified on | 2024/01/12 10:56:01 |
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Basic information
Public title
A confirmation study for effects of synbiotics on reducing body fat
Acronym
A confirmation study for effects of synbiotics on reducing body fat
Scientific Title
A confirmation study for effects of synbiotics on reducing body fat: A randomized, double-blind, placebo-controlled parallel group study
Scientific Title:Acronym
A confirmation study for effects of synbiotics 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 verify the effect of Bifidobacterium with dietary fiber on body fat
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area(Week 12)
Key secondary outcomes
Visceral fat area(Week 8), Abdominal subcutaneous fat area(Week 8, 12), Abdominal total fat area(Week 8, 12), Body weight, Body-mass index, Body fat percentage (impedance method), waist circumference, hip circumference, W/H ratio, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acid,fecal bifidobacteria
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
100g beverage containing bifidobacterium GCL2505 (1.10^10 CFU/mL) and inulin (2g) (once a day for 12 weeks), observation period (1 weeks)
Interventions/Control_2
100g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 12 weeks), observation period (1 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)Males and females aged of 20-64 years at the date of informed consent
2)Subjects of BMI between 23 and 30
3)Subjects who can stop drinking from 2 days before each measurement.
4)Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
Key exclusion criteria
1)Subjects who regularly undertake medications that affect obesity, hyperlipidemia or lipid metabolism
2)Subjects who have a history of severe kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., and undergoing treatment for them (excluding transient treatment such as colds)
3)Subjects who cannot stop taking health foods or supplements that affect obesity, hyperlipidemia or lipid metabolism
4)Subjects who can't limit the ingestion of foods which may affect intestinal microbiota
5)Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test
6)Subjects who regularly use intestinal drugs and laxatives (including strong laxatives)
7)Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption
8)Subjects who declare some allergies to the components of the test product
9)Subjects who has a current or history of drug dependence and/or alcoholism
10)Subjects who have metal in the CT scan measurement site due to surgery, etc.
11) Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators
12) Claustrophobic
13)Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
14) Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past three months from the date of consent, or who plan to participate in others
15) Subjects who are judged unsuitable for this study by principal investigator
Target sample size
120
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
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
Ezaki Glico 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 Joutou-machi,Maebashi-shi,Gunma
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
| 2024 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/15/24/5025
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/15/24/5025
Number of participants that the trial has enrolled
120
Results
Participants consumed a test beverage containing 1 * 10^10 colony-forming units of Bifidobacterium animalis subsp. lactis GCL2505 per 100 g and 2.0 g of inulin per 100 g for 12 weeks. There were significant reductions in visceral fat area and total fat area. The intervention significantly increased the total number of bifidobacteria and affected the levels of several lipid markers.
Results date posted
| 2024 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 07 | Day |
Baseline Characteristics
Participant flow
Number of Intention To Treat: 120
Number of Full Analysis Set: 118
Number of Per Protocol Set: 114
Adverse events
Nothing
Outcome measures
Visceral fat area, Abdominal subcutaneous fat area, Abdominal total fat area
Body weight, Body-mass index,
Body fat percentage (impedance method), waist circumference, hip circumference, W/H ratio, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acid,fecal bifidobacteria
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056177
