Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum Soluble Cluster of Differentiation 14 (sCD14)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are 18-55 years old.
- •Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
- •Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
- •Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).
- •Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
- •Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
- •Participants do not regularly take anti-inflammatory drugs (more than 2x week) and are willing to suspend use of these medications for 3 days leading up to in-lab visits.
- •Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
- •Participants do not use tobacco products or any illicit drugs.
- •Participants have not used antibiotics or probiotics in the last month.
- •Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
- •Participants do not have a pacemaker.
- •Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).
排除标准
- •Participants are not 18-55 years old.
- •Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
- •Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
- •Participants are pregnant or expecting to become pregnant (females only).
- •Participants are postmenopausal (females only).
- •Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
- •Participants have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis). •Participants regularly take anti-inflammatory drugs (more than 2x week) and are not willing to suspend use of these medications for 3 days leading up to in-lab visits.
- •Participants take weight-loss medications (e.g., Ozempic, Wegovy).
- •Participants use tobacco products or any illicit drugs.
- •Participants have used antibiotics or probiotics in the last month.
- •Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
- •Participants have a pacemaker.
结局指标
主要结局
Serum Soluble Cluster of Differentiation 14 (sCD14)
时间窗: Through study completion, up to 1.5 years.
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.
Serum Lipopolysaccharide Binding Protein (LBP)
时间窗: Through study completion, up to 1.5 years.
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.
Serum C-Reactive Protein (CRP)
时间窗: Through study completion, up to 1.5 years.
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.
Heart Rate Variability (HRV)
时间窗: Through study completion, up to 1.5 years.
The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Flow-Mediated Dilation (FMD)
时间窗: Through study completion, up to 1.5 years.
The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Pulse Wave Velocity (PWV)
时间窗: Through study completion, up to 1.5 years.
The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Aortic Aumentation
时间窗: Through study completion, up to 1.5 years.
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.
Augmentation Index (AIx)
时间窗: Through study completion, up to 1.5 years.
The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
次要结局
- Blood Pressure(Through study completion, up to 1.5 years.)
- Glucose(Through study completion, up to 1.5 years.)
- High-Density Lipoprotein Cholesterol (HDL-C)(Through study completion, up to 1.5 years.)
- Triglycerides(Through study completion, up to 1.5 years.)
- Digestive Symptoms(Through study completion, up to 1.5 years.)
研究者
Bryant Keirns
Assistant Professor
Ball State University