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Based on prior research, the investigators are interested in whether an intervention targeting gut health (supplemental fiber for 9 weeks total) will improve vascular health in individuals with obesity. Additionally, the investigators are interested in if this response differs based on whether individuals with obesity have very few heart disease risk factors or several heart disease risk factors.
The investigators will recruit individuals with obesity (body mass index ≥30 kg/m2) from Ball State University Campus and the surrounding community. Participants will be grouped as "metabolically healthy" (0-1 metabolic syndrome risk factors) or "metabolically unhealthy" (≥2 metabolic syndrome risk factors) Participants will be asked to consume inulin for 9 weeks total. Participants will consume 6g of inulin per day during week 1 as a run-in period. The following 8 weeks participants will consume 12g of inulin per day.
Participants will be asked to report for in-lab assessments/visits before the study begins (baseline), halfway through the intervention which starts following the 1-week run-in period (5 weeks), and at the conclusion of the intervention (9 weeks). At all of these assessments, participants will arrive in the morning (roughly 6-10 AM) having fasted for ~10 hours. We will then collect a blood sample, followed by several vascular measurements including flow-mediated dilation, pulse wave analysis, pulse wave velocity, and an electrocardiogram. Body weight and composition will also be assessed using a bioimpedance scale at each visit. Upon completion of each in-lab visit, participants will be asked to wear an ambulatory blood pressure monitoring device for 24 hours and will complete a 3-day food record. Dual-energy X-ray absorptiometry scans will be used to assess body composition at baseline and final study visits. Participants will provide a stool sample collected at home following baseline and final study visits as an optional procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin Supplement | Experimental | Participants will consume 6g of pre-portioned powdered inulin from chicory root daily for one week followed by 12g daily for eight weeks. Participants will fully dissolve it into a habitual cool or room temperature beverage to drink around the same time each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inulin | Dietary Supplement | 6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Soluble Cluster of Differentiation 14 (sCD14) | The investigators will measure fasting sCD14 at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Serum Lipopolysaccharide Binding Protein (LBP) | The investigators will measure fasting LBP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Serum C-Reactive Protein (CRP) | The investigators will measure fasting CRP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Heart Rate Variability (HRV) | The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Flow-Mediated Dilation (FMD) | The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Pulse Wave Velocity (PWV) | The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | The investigators will measure peripheral, central, and ambulatory blood pressure at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | The investigators will measure body composition using bioelectrical impedance and waist circumference at each visit, and dual-energy X-ray absorptiometry at the baseline and final visits. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryant Keirns, PhD | Contact | 765-285-8356 | bryant.keirns@bsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bryant Keirns, PhD | Ball State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Professions Building | Recruiting | Muncie | Indiana | 47306 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D000067329 | Obesity, Metabolically Benign |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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Single arm, open label
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| Through study completion, up to 1.5 years. |
| Aortic Aumentation | The investigators will measure aortic augmentation at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Augmentation Index (AIx) | The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
The investigators will measure fasting glucose at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. |
| Through study completion, up to 1.5 years. |
| High-Density Lipoprotein Cholesterol (HDL-C) | The investigators will measure fasting HDL-C at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Triglycerides | The investigators will measure fasting triglycerides at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| Digestive Symptoms | The investigators will measure digestive symptoms at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion. | Through study completion, up to 1.5 years. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |