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Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects

NCT ID: NCT02151825

Last Updated: 2014-05-30

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

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the gut microbiota composition, body composition and adiposity-related genes and metabolic markers in healthy overweight adult subjects.

Detailed Description

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This is a parallel, double-blind, randomized, placebo controlled trial to determine the effects of a synbiotic formulation (ProSynbiotic) containing 4 billion CFU of a probiotic blend of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii, along with 1 g of the prebiotic inulin and 100 mg of galactooligosaccharide (GOS) on the gut microbiota composition, body composition, expression of genes mediating dietary energy harvest and adiposity, and on adiposity-related metabolic markers in healthy free-living overweight or moderately obese subjects. The duration of the study is 18 weeks, including a 2-week run-in period before randomization of subjects into the synbiotic or placebo group, a 12-week intervention period, and a 4-week follow-up after the end of the intervention. During the intervention period, subjects will be instructed to take 3 capsules of either synbiotic or placebo per day and maintain their habitual diet and physical activity. They will also be asked to document any unusual symptoms or side effects as well as keep a bowel diary. Diet and physical activity will be monitored via 24-h dietary recalls and the global physical activity questionnaire respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels in stool sampled collected at baseline, 6 weeks, 12 weeks and the follow up time point. Body composition will be measured using the BOD POD at baseline, 6 weeks, and 12 weeks. Gene expression levels will be assessed at baseline and 12 weeks in colonocytes (isolated from stool samples) and PBMCs (isolated from blood samples) by qPCR. Metabolic markers will be measured at baseline and 12-weeks in plasma or serum using the respective biochemical- or immuno-assays.

Conditions

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Gut Microbiota Adiposity

Keywords

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Gut microbiota Probiotics Prebiotics Synbiotic Bifidobacterium lactis BB-12 Lactobacillus acidophilus LA-5 Lactobacillus casei 431 Inulin GOS Body Weight Overweight Adiposity Obesity ANGPTL4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Synbiotic

3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)

Group Type EXPERIMENTAL

Synbiotic

Intervention Type DIETARY_SUPPLEMENT

3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)

Placebo

3 capsules of Maltodextrin per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

3 capsules of Maltodextrin per day

Interventions

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Synbiotic

3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 capsules of Maltodextrin per day

Intervention Type OTHER

Other Intervention Names

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Prosynbiotic

Eligibility Criteria

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Inclusion Criteria

* Age between 18-64
* BMI of 25-34.9 and/or a waist circumference \>35 inches for women and \>40 inches for men
* Generally healthy except for overweight or moderately obese
* A signed consent form
* Passed a screening questionnaire and willingness to comply with study procedures
* Lipid levels, fasting glucose, liver function and complete blood counts within the normal reference ranges as measured in a screening blood sample

Exclusion Criteria

* Persons on a weight-loss regimen
* Antibiotic use (\< 3 months before the study)
* Regular probiotic, prebiotic or synbiotic use (\< 1 month before the study)
* Regular use of anti-inflammatory drugs, weight-loss medications or supplements (\< 1 month prior to the study)
* Personal history of cardiovascular disease, hypertension, cancer, type 1 or type 2 diabetes and inflammatory gastrointestinal disorders such as Crohn's disease or colitis
* Smoking
* Consumption of \>2 units of alcohol per day
* Pregnancy or lactation
* Irregular periods, menopause or hormone replacement therapy
* Over 300 minutes of exercise per week
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Standard Process Inc.

INDUSTRY

Sponsor Role collaborator

Texas State University, San Marcos

OTHER

Sponsor Role lead

Responsible Party

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Vatsala Maitin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vatsala Maitin, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas State University

Locations

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Texas State University

San Marcos, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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110021

Identifier Type: OTHER

Identifier Source: secondary_id

2011F7611

Identifier Type: -

Identifier Source: org_study_id