The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Meal Tolerance Assessment
研究概览
简要总结
The objectives of this study are the following: 1) to determine the effect of daily consumption of whole grain barley for six week on risk factors of cardiovascular disease compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of whole grain barley to those of whole grain oats for six weeks to determine if the response to these two grains is different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, 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
- •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
Meal Tolerance Assessment
时间窗: 7 hours
Subjects will provide a baseline blood sample at 15 minutes and 5 minutes prior to consuming a test meal. Subjects will then consume a high fat breakfast of foods such as eggs, buttered English muffins, and donuts. Blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 min following ingestion of the test meal. Measurements will be made for serum triglyceride area under the curve, serum cholesterol, insulin, glucose, and plasma apo B48.
Biomarkers of cardiovascular risk
时间窗: After a 12 hour fast
Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size.
Biomarkers of oxidative stress
时间窗: After 6 weeks of feeding
Nitrites and nitrates, malondialdehyde, lipid hydroperoxides, ox-LDL, resistance of LDL to Cu2+-induced oxidation, FRAP, glutathione, glutathione-S-transferase, super oxide dismutase, PON-1, betaine, homocysteine, total thiols, urinary isoprostanes.
Biomarkers of glucoregulatory control
时间窗: After 6 weeks of feeding
Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin
Biomarkers of inflammation
时间窗: After 6 weeks of controlled feeding
C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM
次要结局
- Microarray and targeted gene expression testing(After 6 weeks of controlled feeding)
- Genotype testing(After 6 weeks of controlled feeding)