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

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Probiotic group; Dietary supplement: Placebo group

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 5, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 5, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Weight loss; Probiotic; Lp-PLA2
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: LW_clinical