Fat Quality and Blood Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood glucose response measured in capillary blood
研究概览
简要总结
The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.
详细描述
The intervention study will have a randomized, double blinded, cross-over design with different test meals consisting of saturated or polyunsaturated fat. The amount of fat will be identical in the test meals, but the fat quality will vary. The test meals are in the form of muffin and spread.
All participants will consume two muffins and minimum 20 g of spread a day for three consecutive days, consisting of either a high proportion of saturated fat or a high proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before and at different time points after the glucose test. One week prior to the intervention week and during "wash-out" (11 days), the participants will consume the control products which are high in saturated fat.
At the screening visit (visit 0) the participants will be asked to limit the intake of dietary fat and fiber from oat and barley one week prior to visit 1 and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period. Individuals fulfilling the inclusion criteria will also be invited to participate in a cross-sectional study for investigating the gut microbiota in a healthy population.
An OGTT will be performed at visit 1, 2, 3 and 4.
The participants will receive test meals after screening and before visit 1, 2, and 3.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18,5 and 27 kg/m2
- •Fasting plasma glucose ≤ 6.1 mmol/l
排除标准
- •Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- •Intestinal diseases such as chron's disease, ulcerative colitis and irritable bowel syndrome.
- •Food allergy and intolerances towards grain and dairy products.
- •Pregnant and lactating
- •Fasting blood glucose ≥ 6.1 mmol/L
- •BMI <18,5 and >27 kg/m2
- •Planned weight reduction and or ± 5% weight change over the past three months.
- •Use of antibiotics last 3 months before study entry and during the study period
- •Use of probiotics the last month before study entry and during the study period
- •Blood donor last 2 months before study entry and or during the study period
- •Not willing to end the use of dietary supplements, including probiotic products, fish oil etc. four weeks prior to study entry and throughout the study period
- •Alcohol consumption > 40g / day
- •Hormone treatments (except contraceptives)
研究组 & 干预措施
Test meal 1: Saturated fat 14.9 E%
Test meal with saturated fat 14.9 E%
干预措施: Saturated fat 14.9 E% (Other)
Test meal 2: Polyunsaturated fat 13.6 E%
Test meal with polyunsaturated fat 13,6 E%
干预措施: Polyunsaturated fat 13.6 E% (Other)
结局指标
主要结局
Blood glucose response measured in capillary blood
时间窗: Change from baseline at day 4
Blood glucose response after oral glucose tolerance test (OGTT) measured in Finger-prick capillary blood samples
Serum Insulin response measured in venous blood samples
时间窗: Change from baseline at day 4
Serum Insulin response after OGTT measured in venous blood samples
次要结局
- Serum triglyceride response(Change from baseline at day 4)
- Serum cholesterol(Change from baseline at day 4)
- Hydrogen breath response measured in expired air(Change from baseline at day 4)
- Free fatty acids(Change from baseline at day 4)
- Microbiota analyses in feces(Change from baseline at day 4)
- Quantitative assessment of metabolites in plasma(Change from baseline at day 4)
- Visual analogue scale (VAS)(Change from baseline at day 4)
- Hunger and satiety hormones (e.g. GLP2, PYY)(Change from baseline at day 4)
- Inflammatory markers (e.g. CRP)(Change from baseline at day 4)
- mRNA analyses in PBMC(Change from baseline at day 4)
- Quantitative assessment of metabolites in urine(Change from baseline at day 4)