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 |
A confirmation study for effects of Bifidobacterium and inulin on increasing basal metabolism rate
A confirmation study for effects of synbiotics on increasing basal metabolism
A confirmation study for effects of Bifidobacterium animalis ssp. lactis GCL2505 and inulin on increasing basal metabolism rate
A confirmation study for effects of synbiotics on increasing basal metabolism
Japan |
None
Not applicable | Adult |
Others
NO
To verify the effect of Bifidobacterium with dietary fiber on basal metabolism
Efficacy
Resting energy expenditure (Week 4)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
100 g beverage containing bifidobacterium GCL2505 (1*10^10 CFU/mL) and inulin (2 g) (once a day for 4 weeks)
100 g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 4 weeks)
20 | years-old | <= |
59 | years-old | >= |
Male and Female
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
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
60
1st name | Takashi |
Middle name | |
Last name | Koikeda |
Shiba Palace Clinic
Chair
105-0013
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
03-5408-1590
jimukyoku@mail.souken-r.com
1st name | Ko |
Middle name | |
Last name | Masuda |
SOUKEN Co., Ltd
Management Division
105-0013
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
03-5408-1555
k_masuda@mail.souken-r.com
Shiba Palace Clinic
Ezaki Glico Co., Ltd
Profit organization
Shiba Palace Clinic Ethics Review Committee
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
03-5408-1599
shiba_palace@s-palace-clinic.com
NO
2024 | Year | 07 | Month | 23 | Day |
Unpublished
Preinitiation
2023 | Year | 02 | Month | 09 | Day |
2023 | Year | 02 | Month | 09 | Day |
2023 | Year | 04 | Month | 14 | Day |
2023 | Year | 06 | Month | 23 | Day |
2023 | Year | 04 | Month | 13 | Day |
2023 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057936
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |