Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation in Healthy and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Changes in levels of circulating triglycerides
研究概览
简要总结
The aim of this project is to elucidate how high-fat meals with different kinds of dairy products affect postprandial responses of lipid metabolism and inflammatory markers in healthy and obese subjects.
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
- 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
- 是
入选标准
- •The study will include both men and women aged 18-70 years with the aim of an even age and gender balance.
- •Participants in the healthy group will need to have a body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference (WC) of <94 cm for men and<80 cm for women.
- •Participants in the obese group will need to have a BMI of ≥25 kg/m2 and a waist circumference of ≥94 cm for men and ≥80 cm for women.
- •All subjects must be willing to eat three slices of bread with a dairy product and jam as breakfast.
排除标准
- •BMI <18.5 kg/m2 or >25 kg/m2 in the healthy group and <25 kg/m2 in the obese group
- •WC ≥94 for men and ≥80 cm for women in the healthy group, <94/80 cm for men/women in the obese group
- •Weight change of ± 5 % of body weight in the last three months
- •TG ≥1.3 mmol/L in the healthy group
- •CRP >10 mg/L
- •Total cholesterol >6.1 mmol/L for subjects 18-29 years, >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects ≥50 years old
- •Blood pressure >160/100 mm Hg
- •Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), coronary heart disease, haemophilia, anaemia (hemoglobin <120 gram/L), gastro intestinal disease and hyperthyroidism (TSH >4 mU/L)
- •Pregnant or lactating
- •Allergic or intolerant to gluten, milk protein and/or lactose
- •Use of medications affecting lipid metabolism or inflammation
- •Unwilling to seponate omega-3 rich supplements four weeks prior to screening and during the study period
- •Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
- •Blood donation two months prior to test day 1 or during the study period
- •Tobacco smoking
- •Excessive regular alcohol consumption (>40 grams per day) or prior to the test day
研究组 & 干预措施
Healthy
Lean subjects (BMI<25) with a waist circumference of <94 cm for men and<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Butter (Other)
Healthy
Lean subjects (BMI<25) with a waist circumference of <94 cm for men and<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Cheese (Other)
Healthy
Lean subjects (BMI<25) with a waist circumference of <94 cm for men and<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Whipped cream (Other)
Healthy
Lean subjects (BMI<25) with a waist circumference of <94 cm for men and<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Sour cream (Other)
Obese
Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Butter (Other)
Obese
Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Cheese (Other)
Obese
Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Whipped cream (Other)
Obese
Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.
干预措施: Sour cream (Other)
结局指标
主要结局
Changes in levels of circulating triglycerides
时间窗: Measured at baseline and 2,4 and 6 hours after intake of test meal
次要结局
- Changes of plasma and urine metabolomics(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in levels of gut hormones(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in total cholesterol and lipoproteins(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in levels of apolipoproteins(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in levels of free fatty acids(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in levels of circulating inflammatory markers(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in levels of circulating endotoxins(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in whole genome transcriptomics in PBMC(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Examine epigenetics through DNA methylation and histone modification(Measured at baseline and 6 hours after intake of test meal)
研究者
Stine Marie Ulven
Professor
University of Oslo