NCT04190706已完成不适用
Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14)
研究概览
简要总结
The aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject.
The inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Body Mass Index of 25 to 35 kg/m2
- •Waist circumference greater than 80 cm for women and than 96 cm for men
- •Daily biscuits consumption
- •Fibers intake <25g/day
排除标准
- •Medical history of digestive surgery or disease
- •Large polyphenols food products consumer (cranberries, red berries, coffee, tea, red wine, fruits and vegetables…)
- •Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- •Current probiotics, prebiotics, fibers complement, and/or any products modulation gut transit
- •Feeding particular diet such as vegetarian diet or hyperprotein diet
- •Current weight loss diet
- •Pregnant or lactating woman or woman who did not use effective contraception
- •Drinking more than 3 glasses of alcohol per day (>30g/day)
- •Smoking more than 5 cigarettes per day
结局指标
主要结局
Change from baseline postprandial plasma endotoxemia binding protein kinetics: LBP (lipopolysaccharide-binding protein) and CD14 (Cluster of differentiation 14)
时间窗: baseline, 8 and 9 weeks
LBP and CD14 proteins will be measured at time 0, 120 and 300 after test meal intake
次要结局
- Change from baseline fasting and postprandial plasma endothelial function markers: Human CVD Panel 2, Lipocalin-2/NGAL, Myeloperoxidase, sICAM-1, sVCAM-1, ADAMTS13, D-dimer, GDF-15, Myoglobin, sP-Selectin, Serum Amyloid A(baseline, 8 and 9 weeks)
- Change from baseline diet intake(baseline, 8 and 9 weeks)
- Change from baseline fasting and postprandial plasma inflammatory markers: MCP-1, RANTES, IFNγ, IL-6, TNF-α, IL-1β, CRPus, adiponectin(baseline, 8 and 9 weeks)
- Change of fasting and postprandial plasma inflammatory endotoxemia LPS (lipopolysaccharide)(baseline, 8 and 9 weeks)
- Change from baseline substrates oxidation(baseline, 8 and 9 weeks)
- Change from baseline stool consistency(nine weeks)
- Change from baseline fasting plasma zonulin(baseline, 8 and 9 weeks)
- Change from baseline plasma metabolites and hormone kinetics : glucose, insulin, triglycerides, non-esterified fatty acids(baseline, 8 and 9 weeks)
- Change from baseline fasting plasma lipids : total cholesterol , HDL cholesterol, LDL cholesterol, triglycerides, non-esterified fatty acids(baseline, 8 and 9 weeks)
- Change from baseline tolerance gastro-intestinal symptoms like bloating ,abdominal rumbling ,flatulence ,abdominal pain, nausea, vomiting(nine weeks)
- Change from baseline body composition(baseline, 8 and 9 weeks)
- Change from baseline stool frequency(nine weeks)
- Change from baseline polyphenols urinary concentrations(baseline, 8 weeks)
- Change from baseline fasting plasma oxidative stress parameters: GSH, GSSG, Glutathion peroxidase/ reductase activity, MDA(baseline, 8 and 9 weeks)
- Change from baseline resting energy expenditure(baseline, 8 and 9 weeks)
- Change from baseline gut microbiota composition(baseline, 8 weeks)
研究者
研究点 (2)
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