An interventional study of Inulin and Placebo in Prediabetes, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention
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.
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 22 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Participants will receive 10 g of inulin powder each day for 6 weeks.
Dietary Supplement: Inulin
Participants will receive 10 g of maltodextrin each day for 6 weeks.
Dietary Supplement: Placebo
The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
Also known as: Prebiotic
The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
Change in insulin sensitivity.
Insulin sensitivity will be assessed via a frequently sampled intravenous glucose tolerance test.
Time frame: Baseline, 6 weeks
Change in metabolic flexibility.
Metabolic flexibility will be measured in skeletal muscle biopsies prior to and 4 hours following a high fat meal.
Time frame: Baseline, 6 weeks
Change in endothelial function.
Flow mediated dilation of the brachial artery will be assessed using duplex ultrasonography with a high resolution linear array transducer according to published guidelines.
Time frame: Baseline, 6 weeks
Change in arterial stiffness.
Arterial stiffness will be measured via carotid femoral pulse wave velocity.
Time frame: Baseline, 6 weeks
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Virginia Polytechnic Institute and State University