Overweight
Conditions
Keywords
Probiotic, Weight loss, Lp-PLA2
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.
Interventions
DIETARY_SUPPLEMENTProbiotic 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.
DIETARY_SUPPLEMENTPlacebo 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up | 12-week follow-up | hs-CRP (mg/dL) |
| HDL Cholesterol at baseline and 12-week follow-up | 12-week follow-up | HDL Cholesterol (mg/dL) |
| LDL Cholesterol at baseline and 12-week follow-up | 12-week follow-up | LDL Cholesterol (mg/dL) |
| Triglyceride at baseline and 12-week follow-up | 12-week follow-up | Triglyceride (mg/dL) |
| Total Cholesterol at baseline and 12-week follow-up | 12-week follow-up | Total Cholesterol (mg/dL) |
Outcome results
None listed