No Evidence of Impact of Seed Oil Intake on Biomarkers of Coronary Artery Disease, Chronic Kidney Disease and Diabetes in Healthy Adults With Overweight and Obesity - Result From a Blinded Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Proteomic biomarkers
研究概览
简要总结
This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. We have developed a sensitive and selective urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded randomised study.
详细描述
The intervention follows a parallel double-blind randomised control design. The intervention duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups; rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely via phone.
Participants allocated to either oil groups are instructed to consume the oils uncooked, as a partial replacement to their habitual fat intake. Participants in the control group are asked to not change any aspect of their diet.
Spot urine samples are collected from all participants at all time points for measurement of the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube, mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.
Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6 weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6 and 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Oils were in identical amber glass bottles labelled A or B. Oils blinded to participants and investigators. However, the control group was unblinded due to them not receiving any intervention
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight adults with a BMI>25 and/or a large waist (Male >102cm and female >88cm),
- •Aged 25-75 years
- •No history of chronic disease of the GI tract
- •Not taking medication (other than the contraceptive pill).
排除标准
- •Pregnant or lactating
- •Allergy to any vegetable oils and vegetable oil-derived products
结局指标
主要结局
Proteomic biomarkers
时间窗: 0, 6, 12 weeks
Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)
次要结局
- Blood lipids(0, 6, 12 weeks)
- Inflammation markers(0, 6, 12 weeks)
- Oxidative stress biomarkers(0, 6, 12 weeks)
研究者
Emilie Combet
Senior lecturer
University of Glasgow