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CompletedNCT02492698Updated Jul 9, 2015

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

A Phase 3 interventional study of Probiotic group and Placebo group in Overweight, sponsored by Yonsei University. Completed. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-09.

Sponsored by Yonsei University · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Overweight

Keywords

  • Probiotic
  • Weight loss
  • Lp-PLA2
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 120 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Browse Yonsei University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Probiotic group

    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.

    Dietary Supplement: Probiotic group

  • Placebo comparator
    Placebo group

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

    Dietary Supplement: Placebo group

Interventions

  • Dietary supplementProbiotic group

    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.

  • Dietary supplementPlacebo group

    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.

06

What researchers measure

Primary outcomes

  1. Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up

    Fat percentage (%)

    Time frame: 12-week follow-up

  2. Fat mass by DEXA at baseline and 12-week follow-up

    Fat mass (g)

    Time frame: 12-week follow-up

  3. Lean body mass by DEXA at baseline and 12-week follow-up

    Lean body mass (g)

    Time frame: 12-week follow-up

  4. 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

    Time frame: 12-week follow-up

Secondary outcomes

  1. Total Cholesterol at baseline and 12-week follow-up

    Total Cholesterol (mg/dL)

    Time frame: 12-week follow-up

  2. HDL Cholesterol at baseline and 12-week follow-up

    HDL Cholesterol (mg/dL)

    Time frame: 12-week follow-up

  3. LDL Cholesterol at baseline and 12-week follow-up

    LDL Cholesterol (mg/dL)

    Time frame: 12-week follow-up

  4. Triglyceride at baseline and 12-week follow-up

    Triglyceride (mg/dL)

    Time frame: 12-week follow-up

  5. High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up

    hs-CRP (mg/dL)

    Time frame: 12-week follow-up

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Oct 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2015
First posted
Jul 9, 2015
Start
Jun 2014
Primary completionActual
Oct 2014
CompletionActual
Jan 2015
Last update
Jul 9, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02492698
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 9, 2015
Start date
Jun 2014
Primary completion
Oct 2014
Completion
Jan 2015
Last update
Jul 9, 2015

Study contacts

Jong Ho Lee, Ph.D.
principal investigator · Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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