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OpenTrials
Completed

NCT Number: NCT01685944

Anti-Obesity Effect of Pediococcus Pentosaceus LP28

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live Pediococcus pentosaceus LP28

Dietary Supplement

Heat-killed Pediococcus pentosaceus LP28

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Body fat

    Time frame: Every 4 weeks (Overall 12 weeks)

  2. BMI

    Time frame: Every day (Overall 14 weeks)

    Body weight will be measured every morning.

Secondary outcomes

  1. Abdominal circumference

    Time frame: Every 4 weeks (Overall 12 weeks)

  2. Serum triglyceride

    Time frame: Every 4 weeks (Overall 12 weeks)

  3. Total cholesterol

    Time frame: Every 4 weeks (Overall 12 weeks)

  4. LDL cholesterol

    Time frame: Every 4 weeks (Overall 12 weeks)

  5. HDL cholesterol

    Time frame: Every 4 weeks (Overall 12 weeks)

  6. Fasting blood glucose

    Time frame: Every 4 weeks (Overall 12 weeks)

  7. Fasting insulin

    Time frame: Weeks 0 and 12

  8. HOMA-R

    Time frame: Weeks 0 and 12

  9. Adiponectin

    Time frame: Weeks 0 and 12

  10. Leptin

    Time frame: Weeks 0 and 12

  11. Resistin

    Time frame: Weeks 0 and 12

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2012
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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