NCT05783466招募中不适用
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Total plasma apolipoprotein B concentration
研究概览
简要总结
It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).
Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18-70 years
- •Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
- •Stable body weight (weight change +/- 5 % for 3 months prior to screening)
- •Consumption of at least 1 serving/day of dairy products made from cow's milk
- •Informed consent
排除标准
- •History of bariatric or digestive surgery or disease interfering with main outcomes
- •Drinking more than 3 glasses of alcohol per day (>30g/day)
- •Pregnancy, parturiency or breastfeeding
- •Food allergies or intolerance to dairy products
- •Dietary restriction (vegetarian or lactovegetarian) or high protein diet
- •Use of dietary supplements
- •Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry
- •Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers.
- •Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)
- •Smoking ≥ 5 cigarettes/day during the past 6 months.
结局指标
主要结局
Total plasma apolipoprotein B concentration
时间窗: day 0 and day 90
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
次要结局
- Anthropometric measurements 2(day 0 and day 90)
- Changes in weight(day 0 and day 90)
- Body mass composition measurements(day 0 and day 90)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.)
- Glucose concentrations after 3-month intervention, measured using standard laboratory methods(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes)
- Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods(day 0 and day 90 for fasting and postprandial measurements. • For postprandial measurements: times 60 minutes-120 minutes -180 minutes -240 minutes -270 minutes -300 minutes -360 minutes)
- Targeted plasma lipidomics after 3-month intervention 4(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Targeted chylomicrons of plasma after 3-month intervention(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Targeted chylomicrons of plasma after 3-month intervention 2(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Targeted chylomicrons of plasma after 3-month intervention 3(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Targeted chylomicrons of plasma after 3-month intervention 4(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Inflammation markers(day 0 and day 90 for fasting and postprandial measurements.)
- Inflammation markers 5(day 0 and day 90 for fasting and postprandial measurements.)
- Inflammation markers 6(day 0 and day 90 for fasting and postprandial measurements.)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.)
- Inflammation markers 4(day 0 and day 90 for fasting and postprandial measurements.)
- Inflammation markers 7(day 0 and day 90 for fasting and postprandial measurements.)
- Platelet activation markers(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements,times 120 minutes-240 minutes-300 minutes -360 minutes.)
- Oxidative stress marker(day 0 and day 90)
- Markers of immune cells 2(day 0 and day 90)
- Intestinal microbiota after 3-month intervention.(day 0 and day 90)
- Intestinal microbiota after 3-month intervention 2(day 0 and day 90)
- Questionnaires on digestive comfort(day 0 and day 90)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes)
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8(day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes)
- Targeted plasma lipidomics after 3-month intervention 2(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Targeted plasma lipidomics after 3-month intervention 3(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Inflammation markers 3(day 0 and day 90 for fasting and postprandial measurements.)
- Markers of immune cells(day 0 and day 90)
- Targeted plasma lipidomics after 3-month intervention(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Questionnaires on physical activity(day 0 and day 90)
- Questionnaires on product satiety(day 0 and day 90)
- Targeted plasma lipidomics after 3-month intervention 5(day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.)
- Inflammation markers 2(day 0 and day 90 for fasting and postprandial measurements.)
- Questionnaires on product appreciation(day 0 and day 90)
- Questionnaires food intake(day 0 and day 90)
- Dietary intake questionnaire(day 0 and day 90)
研究者
研究点 (4)
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