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Completed

NCT Number: NCT02492698

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

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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic group

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Fat percentage by dual-energy x-ray absorptiometry (DEXA) at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Fat percentage (%)

  2. Fat mass by DEXA at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Fat mass (g)

  3. Lean body mass by DEXA at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Lean body mass (g)

  4. Fat area by computed tomography (CT) at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Fat area (cm2) at levels of 1st lumbar (L1) vertebra and 4th lumbar (L4) vertebra

Secondary outcomes

  1. Total Cholesterol at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Total Cholesterol (mg/dL)

  2. HDL Cholesterol at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    HDL Cholesterol (mg/dL)

  3. LDL Cholesterol at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    LDL Cholesterol (mg/dL)

  4. Triglyceride at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Triglyceride (mg/dL)

  5. High sensitivity C-reactive protein (hs-CRP) at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    hs-CRP (mg/dL)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 9, 2015
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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