Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Apolipoprotein B48
研究概览
简要总结
The overall aim of this study is to investigate how dairy products with different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry.
The study will be conducted as a randomized acute cross-over meal study. Apparently healthy men will be recruited in the study. They will on 4 test days consume the 4 dairy products and blood will be drawn the following 8 hours.
详细描述
The overall aim of this study is to investigate how dairy products with similar nutrient content but different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR) and liquid chromatography mass spectrometry (LCMS)-based metabolomics.
The study will be conducted as a randomized acute cross-over meal study. On four different test days (with a minimum of 2 weeks washout period) four dairy products with similar nutrient composition but different structures or textures will be tested. During each meal test a single dairy product (+ bread and water) is served and postprandial blood samples are collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during the 8-hour period and an ad libitum meal is served in the end of the day.
25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.
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)
盲法说明
Due to the characteristics of the study design, blinding of project personnel and participants is not possible. However, statistical analyses of the results will be performed in a blinded fashion.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men
- •18-40 years of age
- •Body mass index (BMI): 18.5-24.9 kg/m^2
- •Non-smoker
- •Haemoglobin concentration ≥8.4 mmol/L
排除标准
- •Dislike for dairy products such as milk, cheese and yoghurt
- •Weight change >3 kg 2 months prior to study
- •Any other blood donation < 3 month prior to study and during study, than the blood donation that is included in this study
- •Intensive physical training (>10 hours of per week)
- •Self-reported eating disorders or irregular eating schedules (e.g. skipping breakfast) and uncommon diets (vegetarians, vegans etc.)
- •Alcohol intake above the recommendation from the Danish Health and Medicines Authority (>21 units of alcohol per week)
- •Night- or shift work
- •Food intolerance and allergies related to test products e.g. lactose and gluten
- •Dietary supplements, if not taken on a regular basis
- •Currently use, or use within previously 3 months of prescription medication, except non-prescription primary analgetica (NSAID and paracetamol) to relieve e.g. head ache and stomach pain, and glucocorticoider for topical use e.g. in ointment and creams.
- •Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, back pain, thyroid disease, heart disease, diabetes, inflammation
- •Disorders: neurological, sleep, diagnosed psychiatric disorder, and gastro intestinal and liver disorders.
- •Surgical treatment of obesity and abdominal surgery
- •Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible
- •Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible
- •Simultaneous participation in other clinical intervention studies
结局指标
主要结局
Apolipoprotein B48
时间窗: 0-8 hour
Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.
Triglyceride
时间窗: 0-8 hour
The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.
次要结局
- Free Fatty Acid (FFA)(0-8 hour)
- Cholesterol (total, LDL and HDL cholesterol)(0-8 hour)
- Apolipoproteins(0-8 hour)
- Insulin(0-8 hour)
- Glucose(0-8 hour)
研究者
Anne Birgitte Raben
professor
University of Copenhagen