Clinical trial NCT02492698: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Keywords: Probiotic
Weight loss
Lp-PLA2
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Fat mass by DEXA at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Lean body mass by DEXA at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Fat area by computed tomography (CT) at baseline and 12-week follow-up
timeFrame: 12-week follow-up
Secondary outcomes:
measure: Total Cholesterol at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: HDL Cholesterol at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: LDL Cholesterol at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Triglyceride at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up
timeFrame: 12-week follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
name: Jong Ho Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: