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

Study Overview
=================
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.

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

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic group
* Dietary Supplement: Placebo group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner. | Dietary Supplement: Placebo group<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, Weight loss, Lp-PLA2