Prebiotics, Gut Microbiota, and Cardiometabolic Health



Status:Completed
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:40 - 70
Updated:3/24/2019
Start Date:January 2014
End Date:July 2018

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The Effect of Prebiotics on Insulin Sensitivity, Metabolic Flexibility, and Cardiovascular Health in Prediabetic Adults.

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.

Inclusion Criteria:

- Men and women; postmenopausal women not taking hormone replacement therapy.

- Fasting glucose between 5.6 - 6.9 mmol/L and/or a 2h plasma glucose between 7.8-11.1
mmol/L following a 75 g oral glucose tolerance test.

- Weight stable for previous 6 months (+/- 2.0 kg).

- Sedentary to recreationally active

- Willing to be randomized to treatment or placebo.

- Verbal and written informed consent.

- No plans to gain/lose weight or change physical activity level.

- Willing to pick up food daily, and consume foods provided for the 6-week controlled
feeding period.

Exclusion Criteria:

- BMI less than 25 kg/m2 or greater than 40 kg/m2 or body mass greater than 300 pounds
due to limit of DEXA.

- Diabetes or diabetes medications

- Prebiotic or probiotic supplement or product consumption in prior 3 months.

- Total cholesterol > 6.2 mmol/L; triglycerides > 4.5 mmol/L.

- Blood pressure > 140/90 mmHg or antihypertensive medications.

- Diagnosed inflammatory disease (e.g. lupus, irritable bowel, periodontal disease, etc)

- Fructo, galacto-, xylo-oligosaccharide intake > 3 g/day.

- Past or current ischemic heart disease, stroke, respiratory disease, endocrine or
metabolic disease, neurological disease, or hematological-oncological disease.

- Smoking, alcohol consumption > 2 servings /d for males and 1 serving/d for females, or
taking medications (including but not limited to statins or other drugs with
anti-inflammatory actions) or antioxidant vitamins or supplements.

- Known allergy, hypersensitivity, or intolerance to inulin.
We found this trial at
1
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Blacksburg, Virginia 24061
Phone: 540-231-3487
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Blacksburg, VA
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