Obesity
Conditions
Brief summary
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.
Interventions
DIETARY_SUPPLEMENTMixture of various probiotics and fermentation products
DIETARY_SUPPLEMENTPlacebo
Sponsors
Biostir, Inc.
MIONA Co., Ltd.
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as based on medical history and physical examination * BMI between 25 and 30 kg/m2 * Willing not to serve as blood donor during the study * Informed consent signed
Exclusion criteria
* Food allergy * Female subjects who are pregnant or nursing a child * Participation in any clinical trial up to 90 days before Day 01 of this study * Renal or hepatic dysfunction * Heart disease * Under medication * Subjects who are taking functional food designed for weight loss or serum lipid reduction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal circumference | Week -4, Week 0, Week 4, Week 12 |
| Visceral fat area by CT scan | Week 0, Week 12 |
| Intestinal flora | Week 0, Week 12 |
| Body fat mass | Week -4, Week 0, Week 4, Week 12 |
| Serum adiponectin and leptin levels | Week 0, Week 12 |
| Fasting serum glucose and HbA1c levels | Week -4, Week 0, Week 4, Week 12 |
| Serum lipid profile | Week -4, Week 0, Week 4, Week 12 |
Countries
Japan
Outcome results
None listed