UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050836 |
|---|---|
| Receipt number | R000057936 |
| Scientific Title | A confirmation study for effects of Bifidobacterium animalis ssp. lactis GCL2505 and inulin on increasing basal metabolism rate |
| Date of disclosure of the study information | 2024/07/23 |
| Last modified on | 2023/07/14 09:20:36 |
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Basic information
Public title
A confirmation study for effects of Bifidobacterium and inulin on increasing basal metabolism rate
Acronym
A confirmation study for effects of synbiotics on increasing basal metabolism
Scientific Title
A confirmation study for effects of Bifidobacterium animalis ssp. lactis GCL2505 and inulin on increasing basal metabolism rate
Scientific Title:Acronym
A confirmation study for effects of synbiotics on increasing basal metabolism
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 basal metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting energy expenditure (Week 4)
Key secondary outcomes
Resting energy expenditure (Week 2), Energy expenditure during exercise (Week 2, 4), Respiratory quotient(Week 2, 4), Respiratory quotient during exercise(Week 2, 4), 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
100 g beverage containing bifidobacterium GCL2505 (1*10^10 CFU/mL) and inulin (2 g) (once a day for 4 weeks)
Interventions/Control_2
100 g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 4 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged of 20-59 years at the date of informed consent
2)Subjects who eat their meals three times a day at roughly the same time
3)Subjects who usually have a stable life rhythm (eating, sleeping, etc.)
4)Subjects who do not usually exercise actively, but are concerned about their health
5)Day shift workers who do not have to go out frequently, such as sales
6)Subjects who usually go to bed around 12:00
7)Subjects who usually finishes their dinner by 21:00
8)Subjects of BMI between 18.5 and 27
Key exclusion criteria
1)Subjects who regularly undertake medications that affect obesity, hyperlipidemia or lipid metabolism
2)Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
3)Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals
4)Subjects who have a history of heart disease, and undergoing treatment for them
5)Subjects who have a drinking habit
6)Subjects who have a night shift
7)Subjects who actively exercise (who goes to the gym at least once a week)
8)Subjects who usually engage in physical labor
9)Subjects who cannot stop taking health foods or supplements that affect obesity, hyperlipidemia, or lipid metabolism
10)Subjects who can't limit the ingestion of foods which may affect intestinal microbiota
11)Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test
12)Subjects whose lifestyle may change during the test period (night shift, long trips, transfer, etc.)
13)Subjects who regularly use intestinal drugs and laxatives (including strong laxatives)
14)Subjects who are suffering from a disease that requires urgent treatment or have serious complications
15)Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption
16)Subjects who declare some food allergies
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 07 | Month | 23 | 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
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057936
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| Registered date | File name |
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