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

Yonsei University

Status and phase: Completed; Phase 3

Conditions: Overweight

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Probiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT02492698

LW_clinical

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic group

Placebo group

Placebo Comparator group

Description:

consumed 2g of powder that did not contain any probiotics, twice a day after breakfast and dinner.

Treatment:

Dietary Supplement: Placebo group