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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