Prebiotics, Gut Microbiota, and Cardiometabolic Health

Completed · Not applicable · Has a placebo group

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT02346838

Run by

Virginia Polytechnic Institute and State University

People needed

22

Starts

2014-01-01

Expected to finish

2018-07-01

Last updated by the study team

2026-03-27

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Polytechnic and State University — Blacksburg, Virginia, United States

Full record on ClinicalTrials.gov

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