Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial
- Conditions
- none
- Registration Number
- JPRN-UMIN000020434
- Lead Sponsor
- Clinical Support Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1)Subjects who take drug including Bifidbacterium or drug having an effect on intestinal functions. 2)Subjects who consecutively take dietary supplement or food including Bifidbacterium (more than three times a week for more than half year), and can't stop those foods during the test period. 3)Subjects who consecutively take dietary supplement or food including N-acetylglucosamine (more than three times a week for more than half year), and can't stop those foods during the test period. 4)Subjects who constantly use drugs and/or Kampo preparation and/or dietary supplement affecting the body fat. 5)Subjects who have colonic disease within 10 years (except polyp or infectious colitis). 6)Subjects who take medical treatment for obesity-related disease. (glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome, obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease) 7)Subjects who have severe disorders in liver function and/or kidney function. 8)Subjects who have medical history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, enterectomy, etc.). 9)Subjects who have allergy to medicine, shrimp, crab, milk or egg. 10)Subjects who can't discontinue dietary supplements for test period. 11)Subjects who are planned to participate in other clinical study. 12)Female with pregnancies, lactating or planning to become pregnant during the study. 13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visceral Fat Area(VFA)
- Secondary Outcome Measures
Name Time Method Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA),Body fat percentage