Anti-Obesity Effect of Pediococcus Pentosaceus LP28

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT01685944
First received: September 12, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Live Pediococcus pentosaceus LP28
Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity

Resource links provided by NLM:


Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Body fat [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Every day (Overall 14 weeks) ] [ Designated as safety issue: No ]
    Body weight will be measured every morning.


Secondary Outcome Measures:
  • Abdominal circumference [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Serum triglyceride [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: Every 4 weeks (Overall 12 weeks) ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • HOMA-R [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Resistin [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Experimental: Live Pediococcus pentosaceus LP28 Dietary Supplement: Live Pediococcus pentosaceus LP28
Experimental: Heat-killed Pediococcus pentosaceus LP28 Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685944

Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Investigators
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01685944     History of Changes
Other Study ID Numbers: eki-619
Study First Received: September 12, 2012
Last Updated: December 17, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014