Clinical trial NCT02151825: Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
Official title: Pilot Study on the Influence of a Synbiotic Formulation (ProSynbiotic) on Gut Microbiota Composition, Adiposity and Selected Markers of Cardiometabolic Health in Overweight or Moderately Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Adiposity
Keywords: Gut microbiota
Probiotics
Prebiotics
Synbiotic
Bifidobacterium lactis BB-12
Lactobacillus acidophilus LA-5
Lactobacillus casei 431
Inulin
GOS
Body Weight
Overweight
Adiposity
Obesity
ANGPTL4
Lead sponsor: Texas State University, San Marcos
Sponsor class: OTHER
Collaborators: name: Standard Process Inc.
First posted: 2014-05-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes to the gut microbiota
timeFrame: 0-weeks (Baseline), 6-weeks (midpoint of intervention), 12-weeks (end of intervention) and 16-weeks (4-weeks after end of intervention)
Secondary outcomes:
measure: Body composition
timeFrame: Baseline, 6-weeks and 12-weeks.
measure: Expression of genes mediating dietary energy harvest and adiposity
timeFrame: Baseline and 12-weeks
measure: Adiposity-related metabolic markers
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Texas State University
state: Texas
Study officials:
affiliation: Texas State University
name: Vatsala Maitin, PhD
role: PRINCIPAL_INVESTIGATOR
References: