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

NCT ID: NCT02492698

Last Updated: 2015-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic group

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.

Group Type EXPERIMENTAL

Probiotic group

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong Ho Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea

Other Identifiers

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LW_clinical

Identifier Type: -

Identifier Source: org_study_id

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