Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in postprandial triglycerides measured as area under the curve (AUC).
研究概览
简要总结
The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.
详细描述
The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume two high-fat meals composed of milk fat with intact MFGM, destroyed MFGM, and without MFGM, respectively. The first meal will be consumed as breakfast and the second meal will be consumed as lunch. Test meals will be isocaloric and with similar macronutrient composition. The meal will consist of a sandwich with a butter-like dairy product.
The three trial days will be completely alike, besides the interventions.
Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize.
The participants will have one intravenous (iv.) access placed in the elbow on the three trial days where blood samples will be collected at 15, 30, 60, 90, 120, 150 and 180 min after each test meal (breakfast and lunch).
Immediately after consuming each of the two test meals, the subjects will take 1,500mg paracetamol to determine ventricular emptying rate using the acetaminophen test. After this, the subjects can lay in the bed and watch TV, iPad, or work on their laptop.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •Written and informed consent
- •HbA1c < 48 mmol/l
排除标准
- •Medicine with an impact on blood glucose, lipid profile, or blood pressure and birth control pills
- •BMI > 30kg/m2
- •Affected screening blood sample as evaluated by the clinical responsible investigator
- •Severe claustrophobia
- •Lactose intolerance
- •Doesn't speak and understand Danish
- •Commitment to special diets
结局指标
主要结局
Difference in postprandial triglycerides measured as area under the curve (AUC).
时间窗: -60 to 180 minutes after first intervention (first meal), 0-180 minuter after second intervention (second high-fat meal)
Difference in triglycerides AUC after the intervention between high-fat meal with intact MFGM, high-fat meal with destroyed MFGM, and high-fat meal without MFGM.
次要结局
- Difference in concentration of LEAP2(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of CCK(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein)(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of apoB48(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of GLP-1(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of FFA(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration concentration of GDF15(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of Ghrelin(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of Insulin(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of glucagon(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of cholesterol (total, LDL and HDL)(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration of GIP(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration concentration of Gastrin(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in concentration concentration of Cytokines(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Metabolic rate(0-420 minutes)
- Difference in concentration of apoB100(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in appetite sensation(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Difference in gastric emptying rate(-60 to 180 minutes after first intervention (first high-fat meal), 0-180 minutes after second intervention (second high-fat meal))
- Ad libitum meal test(420 minutes after start of test day.)
- Difference in glucose concentration(-60 to 360 minutes after first intervention (first high-fat meal))
- Substrate metabolism(0-420 minutes)