Impact of Fat Quality on Postprandial Inflammation (PI:Fat): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Inflammation markers
研究概览
简要总结
This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response.
The main questions it aims to answer are:
- What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
- Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
- Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?
Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.
详细描述
A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be carried out at two sites; one study center is located in Gothenburg, Sweden (Department of Internal Medicine and Clinical Nutrition at the University of Gothenburg) and one study center in Oslo, Norway (Department of Nutrition, University of Oslo).
A total of 20 healthy adults will be recruited and consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours after. Each of the four meals will be separated by a 1 month washout. Subjects will be asked to abstain from rigorous physical activity, alcohol and high-fat foods the day prior to their test meal days.
Four isocaloric high-fat meals with different fatty acid profiles will be compared:
- butter
- coconut oil
- corn oil
- flax seed oil
At test meal days, study outcomes will be assessed at baseline (0h, fasting, pre meal), 30 min, 1h, 2h, 4h and at 6h (endpoint). At these timepoints, blood pressure will be measured and blood glucose sampled through capillary blood. At baseline, 2h, 4h and 6h, blood will be drawn by venipuncture. Urine will be collected when the participants need to void.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >18.5
- •Willingness to eat study meals
排除标准
- •Cardiovascular disease
- •Dyslipidemia
- •Anemia (Hb <100)
- •Habitual intake of anti-inflammatory drugs
- •Recent weight change (>±5%)
- •Pregnancy, lactation
- •Current smoking
研究组 & 干预措施
Flax seed oil
Flax seed oil based meal
干预措施: Fat intake (Other)
Butter
Butter based meal
干预措施: Fat intake (Other)
Coconut
Coconut based meal
干预措施: Fat intake (Other)
Corn oil
Corn oil based meal
干预措施: Fat intake (Other)
结局指标
主要结局
Inflammation markers
时间窗: 0, 2, 4 and 6 hours
Cytokines, chemokines, endothelial factors
次要结局
- Blood pressure(0, 0.5, 1, 2, 4, 6 hours)
- Gene expression(0 and 4 hours)
- Lipidomics(0, 2, 4 and 6 hours)
- Lipoproteins(0, 2, 4 and 6 hours)
- Blood glucose(0, 0.5, 1, 2, 4, 6 hours)