NCT02492698

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

July 1, 2015

Last Update Submit

July 5, 2015

Conditions

Overweight

Keywords

ProbioticWeight lossLp-PLA2

Outcome Measures

Primary Outcomes (4)

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

    Fat percentage (%)

    12-week follow-up

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

    Fat mass (g)

    12-week follow-up

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

    Lean body mass (g)

    12-week follow-up

  • 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

    12-week follow-up

Secondary Outcomes (5)

  • Total Cholesterol at baseline and 12-week follow-up

    12-week follow-up

  • HDL Cholesterol at baseline and 12-week follow-up

    12-week follow-up

  • LDL Cholesterol at baseline and 12-week follow-up

    12-week follow-up

  • Triglyceride at baseline and 12-week follow-up

    12-week follow-up

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

    12-week follow-up

Study Arms (2)

Probiotic group

EXPERIMENTAL

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 group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo group

Interventions

Probiotic groupDIETARY_SUPPLEMENT

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.

Probiotic group
Placebo groupDIETARY_SUPPLEMENT

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.

Placebo group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jong Ho Lee, Ph.D.

    Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 9, 2015

Study Start

June 1, 2014

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

July 9, 2015

Record last verified: 2015-07