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

Phase 3

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Placebo group; Dietary Supplement: Probiotic group

• Registration Number: NCT02492698
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-05
• Last Update Submitted: 2015-07-05
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner.
Probiotic group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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