Obese
Conditions
Interventions
Daily ingestion of 2 capsules containing Bifidobacterium B-3 for 12 weeks.
Daily ingestion of 2 placebo capsules devoid of Bifidobacterium B-3 for 12 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who have BMI ranging from 23 to 30 2.Subjects who give written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: 1.Subjects who have serious disease (cerebrovascular, heart, liver, kidney, gastrointestinal, endocrine metabolic diseases, infectious diseases that requires notification) 2.Subjects with a history of gastro -intestinal related cancer or those who undertake medication or treatment for such disease 3.Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc. 4.Subjects with irritable bowel syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction 5.Subjects who is under medication or treatment for diabetes, dyslipidemia, high blood pressure 6.Subjects who regularly undertakes medication, treatment, functional food, nutraceuticals, or health supplements that affects bowel motion 7.Subjects who regularly take drugs, functional food, nutraceuticals or health supplements that affect serum lipids 8.Subjects who has defecation frequency less than thrice per week, or frequent symptoms of diarrhea 9.Subjects with frequent complaints of post-menopausal symptoms 10.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data 11. Subjects with serious anemia 12. Subjects with a history of allergy to medicine and food 13. Heavy smoker and alcohol addict, or subjects with irregular lifestyle 14.Subjects who donated 400ml whole blood within past 12 weeks or 200ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study 15.Subjects who is pregnant or under lactation, or who is expected to be pregnant during the study 16.Subjects who is currently participating in or who had participated in other clinical trials within the last one month prior to this study 17.Subjects who are judged ineligible by our physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body composition (body weight, body fat percentage, BMI), abdominal visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipids metabolism parameters(T-Cho,HDL-Cho,LDL-Cho,TG,NEFA), blood glucose metabolism parameters (FBG, HbA1c, insulin), abdominal circumference, enteric environment (enterobacterial flora analysis, defecation frequency), inflammatory marker (hs-CRP), liver function (AST, ALT, gamma-GTP, ALP, LDH), total protein, albumin, cytokine (adiponectin, IL-6) | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun Nishihira, M.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed