Gut Microbiome, Adiposity, and Probiotics (GMAP)
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Recent studies have shown that the bacteria in the gut (gut microbiome) can affect adiposity
      levels and inflammation. In animal studies, changing these bacteria has been linked with
      decreased fat mass and inflammation as well as improved metabolism. Probiotics can be a safe
      method of altering the gut microbiome in humans and have shown promising results in adults
      with regards to changing adiposity and inflammatory markers. However, it may also be
      important to provide the right dietary milieu (i.e. high fruit and vegetable/low saturated
      fat diet) in order to see the benefits of probiotics on these physiologic markers. At this
      time, no one has offered probiotics in the context of the right dietary milieu and tested it
      in children. This pilot proposal is innovative because it will be the first to test how well
      probiotics work in the context of a diet high in fruits and vegetables to change the gut
      microbiome, decrease fat mass, and improve inflammatory markers in overweight/obese children.
      This protocol will allow one to better understand the effect of probiotics on these
      physiologic functions and determine acceptability and feasibility of taking daily probiotics.
    

Detailed description: 
      The goal is to study the effect of probiotics on changing the gut microbiome of
      overweight/obese children. Since there appears to be a diet-by-microbiota interaction for
      optimal effects on adiposity, it will be important to administer the probiotics within the
      context of increased fruit/vegetable (F/V) intake and decreased fat intake. Because changes
      in diet alone can also induce changes in the gut microbiota, this study will use a
      double-blind, randomized, placebo-control design to determine whether changes in gut
      microbiota are greater with the addition of probiotics (High F/V diet + Probiotics) compared
      to diet alone (High F/V diet + Placebo). The primary aim is to test the effect of these 2
      arms on changing the gut microbiota, fat mass, and inflammation in children. The study will
      also examine the acceptability of taking probiotics and changes in other physiologic
      measures.

      The Specific aims of this proposal are:

        1. To examine the effect of diet high in F/V +/- probiotics on change in gut microbiota,
           adiposity, and inflammation (measured by C-reactive protein, TNF-a, and IL-6);

        2. To examine the effect of diet high in F/V +/- probiotics on physiologic measures
           including blood pressure, fasting insulin and glucose, and adiponectin;

        3. To determine the acceptability and feasibility of taking daily probiotics over a 12 week
           period.
    

Intervention name(s): Probiotic - VSL#3; Placebo pill - soy protein powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors; Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomized to probiotic or placebo group, and remained in that group for the 12 week study period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other