Anti-Obesity Effect of Pediococcus Pentosaceus LP28
Overview
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.
Full Title of Study: “A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: April 2013
Interventions
- Dietary Supplement: Live Pediococcus pentosaceus LP28
- Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28
- Dietary Supplement: Placebo
Arms, Groups and Cohorts
- Placebo Comparator: Placebo
- Experimental: Live Pediococcus pentosaceus LP28
- Experimental: Heat-killed Pediococcus pentosaceus LP28
Clinical Trial Outcome Measures
Primary Measures
- Body fat
- Time Frame: Every 4 weeks (Overall 12 weeks)
- BMI
- Time Frame: Every day (Overall 14 weeks)
- Body weight will be measured every morning.
Secondary Measures
- Abdominal circumference
- Time Frame: Every 4 weeks (Overall 12 weeks)
- Serum triglyceride
- Time Frame: Every 4 weeks (Overall 12 weeks)
- Total cholesterol
- Time Frame: Every 4 weeks (Overall 12 weeks)
- LDL cholesterol
- Time Frame: Every 4 weeks (Overall 12 weeks)
- HDL cholesterol
- Time Frame: Every 4 weeks (Overall 12 weeks)
- Fasting blood glucose
- Time Frame: Every 4 weeks (Overall 12 weeks)
- Fasting insulin
- Time Frame: Weeks 0 and 12
- HOMA-R
- Time Frame: Weeks 0 and 12
- Adiponectin
- Time Frame: Weeks 0 and 12
- Leptin
- Time Frame: Weeks 0 and 12
- Resistin
- Time Frame: Weeks 0 and 12
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Hiroshima University
- Provider of Information About this Clinical Study
- Principal Investigator: Fumiko Higashikawa, Associate Professor – Hiroshima University
- Overall Official(s)
- Fumiko Higashikawa, PhD, Principal Investigator, Hiroshima University
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