- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346838
Prebiotics, Gut Microbiota, and Cardiometabolic Health
February 28, 2024 updated by: Kevin Davy, Virginia Polytechnic Institute and State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Polytechnic and State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inulin
Participants will receive 10 g of inulin powder each day for 6 weeks.
|
The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
Other Names:
|
Placebo Comparator: Placebo
Participants will receive 10 g of maltodextrin each day for 6 weeks.
|
The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin sensitivity.
Time Frame: Baseline, 6 weeks
|
Insulin sensitivity will be assessed via a frequently sampled intravenous glucose tolerance test.
|
Baseline, 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in metabolic flexibility.
Time Frame: Baseline, 6 weeks
|
Metabolic flexibility will be measured in skeletal muscle biopsies prior to and 4 hours following a high fat meal.
|
Baseline, 6 weeks
|
Change in endothelial function.
Time Frame: Baseline, 6 weeks
|
Flow mediated dilation of the brachial artery will be assessed using duplex ultrasonography with a high resolution linear array transducer according to published guidelines.
|
Baseline, 6 weeks
|
Change in arterial stiffness.
Time Frame: Baseline, 6 weeks
|
Arterial stiffness will be measured via carotid femoral pulse wave velocity.
|
Baseline, 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin P Davy, PhD, Virginia Polytechnic and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 20, 2015
First Posted (Estimated)
January 27, 2015
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prebiotics-Prediabetes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prediabetes
-
Aga Khan UniversityLinnaeus University; Kenyatta UniversityRecruiting
-
Philip KernNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Chonbuk National University HospitalCompletedPreDiabetes
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
University of TorontoInternational Nut and Dried Fruit Council (INC); The National Dried Fruit Trade... and other collaboratorsUnknown
-
National Yang Ming UniversityRecruiting
-
Albert Einstein College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Clinical Nutrition Research Centre, SingaporeSingapore Institute for Clinical SciencesCompleted
-
Northwestern UniversityAllianceChicago; Erie Family Health CentersCompleted
-
Ohio UniversityTouro University, CaliforniaCompletedPreDiabetes
Clinical Trials on Inulin
-
Scottish Universities Environmental Research CentreUniversity of Glasgow; NHS Greater Clyde and GlasgowCompletedObesity | OverweightUnited Kingdom
-
Eskisehir Osmangazi UniversityUnknownFunctional Constipation
-
Maastricht University Medical CenterCompleted
-
Imperial College LondonUniversity of GlasgowCompletedAppetite Regulation | Healthy Obesity, MetabolicallyUnited Kingdom
-
University of Illinois at Urbana-ChampaignRenal Research InstituteCompletedBone Diseases, Endocrine | Nutritional and Metabolic DiseasesUnited States
-
Augusta UniversityAmerican Gastroenterological Association FoundationCompletedInvestigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response StudyHealthy VolunteersUnited States
-
University of ReadingUnknownOverweight and ObesityUnited Kingdom
-
Second Xiangya Hospital of Central South UniversityNot yet recruitingType 1 Diabetes Mellitus | Autoimmune DiabetesChina
-
National Institute of Diabetes and Digestive and...University of Pennsylvania; George Washington UniversityUnknownChronic Kidney DiseasesUnited States
-
CindetecNucitec SA de CVCompleted