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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492698
• Other study ID #: LW_clinical
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2015
• Last updated: July 5, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Overweight

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up	Fat percentage (%)	12-week follow-up	Yes
Primary	Fat mass by DEXA at baseline and 12-week follow-up	Fat mass (g)	12-week follow-up	Yes
Primary	Lean body mass by DEXA at baseline and 12-week follow-up	Lean body mass (g)	12-week follow-up	Yes
Primary	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	Yes
Secondary	Total Cholesterol at baseline and 12-week follow-up	Total Cholesterol (mg/dL)	12-week follow-up	Yes
Secondary	HDL Cholesterol at baseline and 12-week follow-up	HDL Cholesterol (mg/dL)	12-week follow-up	Yes
Secondary	LDL Cholesterol at baseline and 12-week follow-up	LDL Cholesterol (mg/dL)	12-week follow-up	Yes
Secondary	Triglyceride at baseline and 12-week follow-up	Triglyceride (mg/dL)	12-week follow-up	Yes
Secondary	High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up	hs-CRP (mg/dL)	12-week follow-up	Yes