Acute Heart Health Benefits of Whole Grain Barley and Oats in Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Lipid Tolerance Test
研究概览
简要总结
The objectives of this study are the following: 1) to determine the acute effect of whole grain barley on risk factors of cardiovascular disease compared to a diet low in whole grain, and 2) to compare the effects of whole grain barley to those of whole grain oats to determine if the response to these two grains is similar.
详细描述
Whole grains contain bioactive components that may contribute to reduced risk of cardiovascular disease, and there may be significant differences among whole grain sources with respect to ability to alter biomarkers of cardiovascular disease. This acute study is designed to determine if whole grain barley improves postprandial lipid metabolism and improves endothelial function. Further, we will determine if acute consumption of whole grain barley versus acute consumption of whole grain oats results in differential response with respect to biomarkers of cardiovascular disease risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between the ages of 25-70 years
- •Body mass index (BMI) ≥ 19 and ≤ 38
- •Willingness and ability to make scheduled appointments at clinical site as required by study protocol
排除标准
- •Do not regularly consume breakfast or dislike cereal for breakfast
- •Known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
- •Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- •Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- •Fasting triglycerides > 300 mg/dL
- •Fasting glucose > 126 mg/dL
- •Use of cholesterol lowering medication
- •Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
- •Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing
- •History of bariatric or certain other surgeries related to weight control
- •History of major surgery within 3 months of enrollment
- •Smokers or other tobacco users (during 6 months prior to the start of the study)
- •Antibiotic use during the intervention or for 3 months prior to the intervention period
- •History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- •Volunteers who have lost 10% of body weight within the last 6 months
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Lipid Tolerance Test
时间窗: After 3 consecutive days of controlled feeding.
Participants will come in after a 12-hour fast for a lipid tolerance test. Specifically, participants will consume a treatment breakfast meal and blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 minutes following ingestion of the treatment meal.
EndoPAT
时间窗: After 3 consecutive days of controlled feeding
Endothelial function will be assessed by measuring endothelium-dependent flow mediated dilation of the peripheral bed (EndoPAT, Itamar Medical, Israel). Immediately after the test, a blood sample will be collected for measurement of serum triglycerides.
次要结局
- Genetic testing(After 3 consecutive days of controlled feeding)
- Microarray and targeted gene expression testing(After 3 consecutive days of controlled feeding)