None
Conditions
Interventions
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 fo
Sponsors
Shiba Palace Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting energy expenditure (Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKo Masuda
SOUKEN Co., Ltd Management Division
Outcome results
None listed