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Completed

NCT Number: NCT02050555

Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

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 drugs 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
  • History of severe disease and/or major surgery

Treatment and study plan

Placebo

Dietary Supplement

Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

Dietary Supplement

Primary outcomes

  1. Change in BMI from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  2. Change in body fat mass (percentage) from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

Secondary outcomes

  1. Change in abdominal circumference from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  2. Change in visceral fat area by CT scan from baseline

    Time frame: Weeks 0 and 12

  3. Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline

    Time frame: Weeks 0 and 12

  4. Change in fasting plasma glucose from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  5. Change in serum triglyceride from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  6. Change in serum total cholesterol from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  7. Change in serum LDL cholesterol from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  8. Change in serum HDL cholesterol from baseline

    Time frame: Every 4 weeks (Overall 12 weeks)

  9. Change in fasting insulin from baseline

    Time frame: Weeks 0 and 12

  10. Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline

    Time frame: Weeks 0 and 12

    HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Marukome Co., Ltd.

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Aug 11, 2014

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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