Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
Condition: Gut Microbiota; Adiposity
MeSH terms: Overweight; Obesity
Study type: Interventional

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.
    

Intervention name(s): Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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); 3 capsules of Maltodextrin per day
Other intervention name(s): Prosynbiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
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