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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014