Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pulse wave analysis
研究概览
简要总结
Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease risk. The investigators aim to understand vascular health in females with a "healthy" BMI with differing amounts of body fat and muscle mass. We will have participants come to the lab for two different study visits. At one visit, participants will eat a meal high in fat, and at the other visit, participants will undergo a stress task.
详细描述
The investigators will recruit females with a BMI in the normal (18.5-24.9 kg/m2) from the Ball State University campus and surrounding communities. Each participant will complete a meal trial and a stress trial in a randomized crossover design. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will consume a high-fat, Western style meal consisting of two Jimmy Deans Breakfast Bowls (sausage; 68 g fat; 880 kcal). Following completion of the meal, blood samples will also be collected 1, 2, 3, and 4 hours after the meal. Vascular measurements will be repeated 2 and 4 hours after the meal. Blood will be collected and stored as serum in order to measure triglycerides, HDL-C, and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
At the stress trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will undergo the stress task. Then, blood samples will be collected at 10, 60, and 90 minutes after the stress task. Blood will be collected and stored as serum in order to measure epinephrine and inflammatory markers. Vascular measurements will also be repeated 10 and 90 minutes after the stress task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •You are 18-50 years old
- •Your biological sex is female
- •BMI is in "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- •You are not pregnant or expecting to become pregnant
- •You are not postmenopausal
- •You have not been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
- •You have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- •You do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs.
- •You do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs
- •You do not have a pacemaker.
- •You do not have dietary restrictions prohibiting you from eating the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- •You are able to stay in the supine position in the dark for at least 10 minutes
排除标准
- •You are not 18-50 years old
- •Your biological sex is not female
- •Your BMI is not in the "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- •You are pregnant or expecting to become pregnant (females only)
- •You are postmenopausal
- •You have been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
- •You have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- •You regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs.
- •You use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs
- •You have a pacemaker.
- •You do have dietary restrictions prohibiting you from eating the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- •You are unable to stay in the supine position in the dark for at least 10 minutes
研究组 & 干预措施
High-fat meal trial
During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls.
干预措施: high-fat meal (Other)
Stress trial
During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress.
结局指标
主要结局
Pulse wave analysis
时间窗: Through study completion, up to 1 year.
The investigators will measure PWA (i.e., augmentation index, augmentation index normalized to a heart rate of 75bpm, aortic/peripheral blood pressure) at baseline, 2-hours, and 4-hours after meal trial using Sphygmacor Xcel System. The investigators will measure PWA at baseline, post-stress task, and 90-minutes after the stress task.
Flow-mediated dilation
时间窗: Through study completion, up to 1 year.
The investigators will measure FMD at baseline, 2-hours, and 4-hours after meal trial. The investigators will measure FMD at baseline, post-stress task, and 90-minutes after the stress task.
Pulse wave velocity
时间窗: Through study completion, up to 1 year.
The investigators will measure PWV at baseline, 2-hours, and 4-hours after meal trial using the Sphygmacor Xcel System. The investigators will measure PWV at baseline, post-stress task, and 90-minutes after the stress task.
次要结局
- Serum interleukin-6 (IL-6)(Through study completion, up to 1 year.)
- Serum high-density lipoprotein cholesterol (HDL-C)(Through study completion, up to 1 year.)
- Beat-to-beat systolic and diastolic blood pressure (SBP/DBP)(Through study completion, up to 1 year.)
- Serum triglycerides(Through study completion, up to 1 year.)
- Serum epinephrine(Through study completion, up to 1 year.)
- Heart rate variability (HRV)(Through study completion, up to 1 year.)
- Serum soluble CD14 (sCD14)(Through study completion, up to 1 year.)
- Serum lipopolysaccharide binding protein (LBP)(Through study completion, up to 1 year.)