Reason to Season; Flavors to Increase Vascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To characterize the time course of herbs/spice action on endothelial function as measured by Flow Mediated Vasodilation (FMD) over 24 h using a challenge meal paradigm individualized per subject energy requirements to maintain body weight.
研究概览
简要总结
Scientific evidence is growing on the health benefits of herbs/spices. The study is interested in understanding how various herb and spice blends influence the function of blood vessels. The study is also interested in how blood sugar, the insulin hormone and immune cells may be related to how well the blood vessels function. Herbs and spices have components called phytochemicals that may be related to how well blood vessels function. The study is planned to investigate these relationships.
After qualifying to participate in the research study, participants will be asked to come to the Clinical Nutrition Research Center (CNRC) for four on-site Study Days, each lasting for about 8 hours with a 40 min followup to measure vessels' function the next morning. On each Study Day, different amounts of herbs/spices will be included in a breakfast meal. The herbs and spices are purchased in the grocery store and are Italian herbs, cinnamon, and a mix of pumpkin pie spices (cinnamon, ginger, clove, nutmeg).
All meals will be prepared in the CNRC's kitchen using foods and ingredients purchased at the local grocery store. Blood collection and blood vessel function tests will be performed during the Study Day using typical procedures used in hospitals, doctor offices, and clinics.
详细描述
This clinical trial is a single-center randomized, blinded, multi-arm, within subjects, cross over design and features a repeated postprandial sampling paradigm to evaluate the effects of herbs/spices on vascular function in individuals who are overweight or moderately obese after consuming a standardized challenge meal. Subjects will undergo 4 Study Days at least 3 days apart. On each Study Day subject will receive a standardized meal made with: salt and pepper only (Control condition) or the same meal with up to 6 gram herbs/spice mix or Italian herb mix or cinnamon.Each Study Day will last about 8 h with a 40 min follow up the following morning to complete a 24 h set of procedures. The 24 h assessment allows for assessment of clinical effects over an extended time frame.
STUDY PROCEDURES:
- Screening Visit:
Interested subjects will be asked to come to the Clinical Nutrition Research Center (CNRC) on the IIT (Illinois Tech) Campus, Chicago, IL, where the study will take place for all in person visits. The screening visit is the first visit and will be used to determine if an interested person is eligible to participate in the study. The screening visit will take 2 hours. Prospective subjects must read, sign and date a written Institutional Review Board approved Informed Consent Form prior to performing any study procedure. One of our Study investigators will go through the inform consent (ICF) with subject comprehensively to explain all study related activities as mentioned in the ICF form.
At the on-site screening visit, subject will be asked to arrive after overnight fasting for 10-14 hours and be well-hydrated. Subjects will be instructed to drink plenty of water the 24 hours before the screening visit to ensure they are well hydrated (ie., aim for intake of at least 8-10 cups over 24 h). They will also be asked to abstain from vigorous exercise 12 h before the visit. Light activity is acceptable. A series of procedures will be conducted to determine eligibility to participate in the study, including venous or capillary blood sampling (by finger prick) to test blood glucose (to ensure fasting status and inclusion criteria), anthropometric measurements (height, weight, waist circumference, body composition), Body Mass Index (BMI, calculated from height and weight) calculation, vital sign measurements (blood pressure and heart rate), body temperature measurement (by ear thermometer), and completion of a series of questionnaires relating to their general health and lifestyle. For vital sign measurements, subjects will sit in a comfortable chair, feet uncrossed and on the floor and will be asked to rest quietly for 5 minutes before measuring blood pressure and heart rate. Arm vein will be assessed using a vein access scale test.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 25 and 35 kg/m2
- •Aged over 18 years old
- •Able to provide informed consent and comply with study procedures
- •Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
- •People with no documented disease condition that would interfere with the study endpoints (ie., Cardiovascular disease (CVD), diabetes, hypertension (diagnosed high blood pressure), major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints.
- •Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
- •Premenopausal women are studied at the same time of the month during the follicular phase of their menstrual cycle (first 14 days of cycle).
排除标准
- •Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
- •Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes
- •Unstable use of any medication/supplement - Have a history of cancer, except for non-melanoma skin cancer within past 5 years
- •Addicted to drugs and/or alcohol (>4 drinks/day)
- •Have been exposed to any non-registered drug product within last 30 days.
- •Working overnight (e.g. 3rd shift of overnight workers)
- •Have allergies/intolerances to cinnamon, Italian herbs, or other spices or study foods
- •Excessive exercisers or trained athletes
- •Extreme dietary habits (i.e., vegan)
- •Excessive coffee/tea drinker (> 4cups/day)
- •Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months)
- •Donated blood within last 3 months
- •Female who is pregnant, planning to be pregnant, or breastfeeding
- •The individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
To characterize the time course of herbs/spice action on endothelial function as measured by Flow Mediated Vasodilation (FMD) over 24 h using a challenge meal paradigm individualized per subject energy requirements to maintain body weight.
时间窗: Baseline(T0)-24 hours
Flow mediated vasodilation (FMD): Ultrasound imaging of the brachial artery is a non-invasive technique that assesses endothelial-dependent relaxation and is used as a surrogate marker of large vessel (macrovascular) endothelial function. FMD will be studied in the brachial (arm) artery of all subjects using standardized methods recommended by the American College of Cardiology
次要结局
- Changes in plasma glucose concentration-response between 4 treatments(Baseline(T0)-24 hours)
- Changes in inflammation signaling response between 4 treatments(Baseline (T0)-7 hours)
- Changes in plasma insulin concentration-response between 4 treatments(Baseline(T0)-24 hours)