The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
研究概览
简要总结
The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.
详细描述
A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme.
Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male aged 40-65 years
- •BMI 25-35kg/m2
- •nonsmoking
- •waist circumference =/> 94cm and at least one other CVD risk factor (elevated LDL-C (> 130 mg/dL), CRP (> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL))
- •low herb/spice consumers (consumption <1/day)
排除标准
- •Chronic disease risk factors that are diagnostic of diabetes (fasting glucose > 126 mg/dL) or hypertension (SBP >160 mm Hg or DBP > 100 mm Hg).
- •Prescription of anti-hypertensive or glucose lowering drugs.
- •Established CVD, stroke, diabetes, liver, kidney or autoimmune disease
- •Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals
- •weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study
- •vegetarianism
研究组 & 干预措施
Spice 2g
Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
干预措施: Herbs and spices (Other)
Control
Consumption of a high fat meal (1000kcal, 45g fat)
干预措施: High fat meal (Other)
Spice 2g
Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
干预措施: High fat meal (Other)
Spice 6g
Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
干预措施: Herbs and spices (Other)
Spice 6g
Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
干预措施: High fat meal (Other)
结局指标
主要结局
Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
时间窗: Change from baseline at 2 hours and 4 hours after meal consumption
次要结局
- Inflammatory cytokines in isolated peripheral blood mononuclear cells(Change from baseline during the 4 hours after meal consumption)
- Plasma Inflammatory cytokines(Change from baseline during the 4 hours after meal consumption)
- Insulin(Change from baseline during the 4 hours after meal consumption)
- Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)(Change from baseline during the 4 hours after meal consumption)
- Glucose(Change from baseline during the 4 hours after meal consumption)
- Plasma nitrite and nitrate(Change from baseline during the 4 hours after meal consumption)
- Lipids and lipoproteins(Change from baseline during the 4 hours after meal consumption)
- Oxidative stress(Change from baseline during the 4 hours after meal consumption)
- Plasma and Urine Metabolomic profiling(Change from baseline during the 4 hours after meal consumption)