Obesity
Conditions
Brief summary
This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.
Interventions
DIETARY_SUPPLEMENTLive Pediococcus pentosaceus LP28
DIETARY_SUPPLEMENTHeat-killed Pediococcus pentosaceus LP28
DIETARY_SUPPLEMENTPlacebo
Sponsors
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 25-30 kg/m2
Exclusion criteria
* Taking medicines or functional food that may affect body weight or body fat * Pregnant or nursing a child * Participation in any clinical trial within 90 days of the commencement of the trial * Renal or hepatic dysfunction * Heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body fat | Every 4 weeks (Overall 12 weeks) | — |
| BMI | Every day (Overall 14 weeks) | Body weight will be measured every morning. |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol | Every 4 weeks (Overall 12 weeks) |
| LDL cholesterol | Every 4 weeks (Overall 12 weeks) |
| HDL cholesterol | Every 4 weeks (Overall 12 weeks) |
| Fasting blood glucose | Every 4 weeks (Overall 12 weeks) |
| Abdominal circumference | Every 4 weeks (Overall 12 weeks) |
| HOMA-R | Weeks 0 and 12 |
| Adiponectin | Weeks 0 and 12 |
| Leptin | Weeks 0 and 12 |
| Resistin | Weeks 0 and 12 |
| Fasting insulin | Weeks 0 and 12 |
| Serum triglyceride | Every 4 weeks (Overall 12 weeks) |
Countries
Japan
Outcome results
None listed