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Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults

Primary Purpose

Overweight

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Probiotic group
Placebo group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Probiotic, Weight loss, Lp-PLA2

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 20 and 65 years
  • Nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL)
  • Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)

Exclusion Criteria:

  • Constant consumption of any probiotics products within 1 month before screening
  • Unstable body weight (body weight change > 1 kg within 3 months before screening)
  • Hypertension
  • Type 2 diabetes
  • Cardiovascular disease
  • Cerebrovascular disease
  • Thyroid disease
  • Dietary supplementation within 6 months before screening
  • Pregnancy or breast-feeding
  • Medication affecting body weight, energy expenditure, glucose control or antibiotic treatment within 3 months before screening
  • Acute or chronic infections
  • Liver disease
  • Kidney disease
  • Gastrointestinal disease
  • Cancer
  • Medication or alcohol abuse
  • Any other acute or chronic disease requiring treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic group

    Placebo group

    Arm Description

    consumed 2 g of powder of a dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032, twice a day after breakfast and dinner.

    consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner.

    Outcomes

    Primary Outcome Measures

    Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
    Fat percentage (%)
    Fat mass by DEXA at baseline and 12-week follow-up
    Fat mass (g)
    Lean body mass by DEXA at baseline and 12-week follow-up
    Lean body mass (g)
    Fat area by computed tomography (CT) at baseline and 12-week follow-up
    Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra

    Secondary Outcome Measures

    Total Cholesterol at baseline and 12-week follow-up
    Total Cholesterol (mg/dL)
    HDL Cholesterol at baseline and 12-week follow-up
    HDL Cholesterol (mg/dL)
    LDL Cholesterol at baseline and 12-week follow-up
    LDL Cholesterol (mg/dL)
    Triglyceride at baseline and 12-week follow-up
    Triglyceride (mg/dL)
    High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up
    hs-CRP (mg/dL)

    Full Information

    First Posted
    July 1, 2015
    Last Updated
    July 5, 2015
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02492698
    Brief Title
    Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
    Official Title
    Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.
    Detailed Description
    A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age between 20 and 65 years, nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2). Over a 12 week test period, the probiotic group consumed 2 g of powder twice a day containing L. curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product without probiotics for 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    Probiotic, Weight loss, Lp-PLA2

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic group
    Arm Type
    Experimental
    Arm Description
    consumed 2 g of powder of a dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032, twice a day after breakfast and dinner.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic group
    Intervention Description
    The 2 g of probiotic powder contained 0.1 g of Lactobacillus curvatus HY7601, 0.1 g of Lactobacillus plantarum KY1032, 1.24 g of crystalline cellulose, 0.5 g of lactose, and 0.06 g of blueberry-flavoring agent.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo group
    Intervention Description
    The 2 g of placebo powder contained 1.34 g of crystalline cellulose, 0.6 g of lactose, and 0.06 g of blueberry-flavoring agent.
    Primary Outcome Measure Information:
    Title
    Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
    Description
    Fat percentage (%)
    Time Frame
    12-week follow-up
    Title
    Fat mass by DEXA at baseline and 12-week follow-up
    Description
    Fat mass (g)
    Time Frame
    12-week follow-up
    Title
    Lean body mass by DEXA at baseline and 12-week follow-up
    Description
    Lean body mass (g)
    Time Frame
    12-week follow-up
    Title
    Fat area by computed tomography (CT) at baseline and 12-week follow-up
    Description
    Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra
    Time Frame
    12-week follow-up
    Secondary Outcome Measure Information:
    Title
    Total Cholesterol at baseline and 12-week follow-up
    Description
    Total Cholesterol (mg/dL)
    Time Frame
    12-week follow-up
    Title
    HDL Cholesterol at baseline and 12-week follow-up
    Description
    HDL Cholesterol (mg/dL)
    Time Frame
    12-week follow-up
    Title
    LDL Cholesterol at baseline and 12-week follow-up
    Description
    LDL Cholesterol (mg/dL)
    Time Frame
    12-week follow-up
    Title
    Triglyceride at baseline and 12-week follow-up
    Description
    Triglyceride (mg/dL)
    Time Frame
    12-week follow-up
    Title
    High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up
    Description
    hs-CRP (mg/dL)
    Time Frame
    12-week follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 20 and 65 years Nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood glucose <200 mg/dL) Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2) Exclusion Criteria: Constant consumption of any probiotics products within 1 month before screening Unstable body weight (body weight change > 1 kg within 3 months before screening) Hypertension Type 2 diabetes Cardiovascular disease Cerebrovascular disease Thyroid disease Dietary supplementation within 6 months before screening Pregnancy or breast-feeding Medication affecting body weight, energy expenditure, glucose control or antibiotic treatment within 3 months before screening Acute or chronic infections Liver disease Kidney disease Gastrointestinal disease Cancer Medication or alcohol abuse Any other acute or chronic disease requiring treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jong Ho Lee, Ph.D.
    Organizational Affiliation
    Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults

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