Prebiotics, Gut Microbiota, and Cardiometabolic Health
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week
      feeding study in which they will randomized to receive either 10 g/day of inulin or placebo.
      All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,)
      controlled for micronutrient content for 6 weeks to avoid the potential confound of
      individual differences in diet on gut microbiota. Measurements of intestinal permeability,
      insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and
      following the controlled feeding period. Stool samples will be collected to assess gut
      microbial communities.
    

Detailed description: 
      Prebiotics have been defined as "selectively fermented ingredients that result in specific
      changes in the composition and/or activity of the gastrointestinal microbiota, thus
      conferring health benefit(s) upon host health". Commonly used prebiotics are inulin-type
      fructans, fructo-oligosaccharides, xylo-oligosaccharides and galacto-oligosaccharides and
      while all prebiotics are fibers, not all fibers are prebiotics. The proliferation of a
      targeted bacterial species, in particular, Bifiodobacterium spp. and Lactobacillus spp.
      contribute to host cardiometabolic health in many ways including, but not limited to, short
      chain fatty acid production and, modulation of gut barrier function, endotoxin
      concentrations, inflammatory pathways, and energy metabolism however, to our knowledge the
      potential benefits of prebiotic supplementation on cardiometabolic dysfunction has received
      little attention. Although the concept that dysbiosis of the gut microbiota leads to
      metabolic endotoxemia and increased risk of cardiometabolic disease is novel, very little
      information is available in humans. The significance of our proposal includes providing proof
      of concept efficacy of prebiotic supplementation with inulin on cardiometabolic dysfunction
      and assessing its relation with changes in gut bacterial communities, intestinal
      permeability, and metabolic endotoxemia in prediabetes, a condition affecting a substantial
      segment of the population. Our study could lead to the identification of prebiotic
      supplementation with inulin as a simple and efficacious strategy for reducing cardiometabolic
      risk in prediabetes which could change clinical practice by informing dietary recommendations
      and increasing acceptance of prebiotics by the scientific and medical community.
    

Intervention name(s): Inulin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.; The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
Other intervention name(s): Prebiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prediabetes, prebiotics, metabolic endotoxemia