NCT01685944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

September 12, 2012

Last Update Submit

February 25, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Body fat

    Every 4 weeks (Overall 12 weeks)

  • BMI

    Body weight will be measured every morning.

    Every day (Overall 14 weeks)

Secondary Outcomes (11)

  • Abdominal circumference

    Every 4 weeks (Overall 12 weeks)

  • Serum triglyceride

    Every 4 weeks (Overall 12 weeks)

  • Total cholesterol

    Every 4 weeks (Overall 12 weeks)

  • LDL cholesterol

    Every 4 weeks (Overall 12 weeks)

  • HDL cholesterol

    Every 4 weeks (Overall 12 weeks)

  • +6 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Live Pediococcus pentosaceus LP28

EXPERIMENTAL
Dietary Supplement: Live Pediococcus pentosaceus LP28

Heat-killed Pediococcus pentosaceus LP28

EXPERIMENTAL
Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28

Interventions

Live Pediococcus pentosaceus LP28DIETARY_SUPPLEMENT
Live Pediococcus pentosaceus LP28
Heat-killed Pediococcus pentosaceus LP28DIETARY_SUPPLEMENT
Heat-killed Pediococcus pentosaceus LP28
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25-30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

JP(1)