Investigating Blood Lipid Responses to Dietary Macronutrient Content
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in plasma triglyceride concentrations [mmol/L]
研究概览
简要总结
The macronutrient composition of a diet (proportions of carbohydrates, fats and proteins) strongly influences the way the body stores and utilises substrates (e.g., fats and sugars), which in turn influences the risk of developing cardiometabolic diseases (e.g., coronary artery disease or insulin resistance). The optimal dietary composition to lower the risk of cardiometabolic disease is unknown.
In a randomized, parallel design, this study will investigate how the overconsumption of carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from metabolic disease. By genotyping participants, the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism will be examined.
详细描述
Dietary and lifestyle interventions are central to lowering the risk and preventing the development of metabolic disease, including non-alcoholic fatty liver disease, type 2 diabetes, and cardiovascular disease. There is, however, no one fits all dietary approach, and in the context of diets where an individual is not gaining or losing weight (known as eucaloric), the optimal macronutrient composition associated with a reduced risk of metabolic disease and dyslipidemia is highly debated. For instance, eating less of one macronutrient implies eating more of another; a reduction in the intake of dietary carbohydrates is met by an increase in dietary fats. How this affects one's metabolic health in the setting when someone is not gaining or losing body weight is unclear.
Therefore, this study aims to provide an understanding of the effect that the quantity of specific dietary macronutrients (e.g., carbohydrates, fats) have on plasma triglyceride concentrations in both the fasting and postprandial state, liver fat content and metabolism, and cardiac fat content and function. An individual's genotype affects the metabolic response to a shift in dietary macronutrient content and this will be examined in this study.
Sixty volunteers free from metabolic disease will be recruited into a randomized, parallel-armed dietary intervention study. Participants will consume either a low carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days. Diets will be eucaloric (i.e., designed to meet the individual participant's energy requirements). Comprehensive in vivo metabolic and physiological testing will be performed before and after the experimental diet to document the effects of the overconsumption of specific macronutrients (i.e., fats or carbohydrates) on liver and lipid metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged ≥18 to ≤65 years
- •Body mass index (BMI) ≥19 to ≤35 kg/m2
- •No medical condition or relevant drug therapy that is known to affect the liver, adipose tissue, or cardiac metabolism.
- •Weight stable for the previous 3 months
排除标准
- •Aged <18 or >65 years
- •BMI <19 or >35 kg/m2
- •A blood haemoglobin <135 mg/dL for men and <120 mg/dL for women
- •Donated (or lost) ≥250 mL of blood in the previous two months
- •On a weight loss diet or decreased their body weight by >5% in the previous 3 months
- •Currently adhering to or have consumed in the previous 3 months a diet with a notably altered macro-nutrient content (e.g. high-fat - low-carbohydrate diet)
- •Have increased their body weight by >5% in the previous 3 months
- •Any metabolic condition or relevant drug therapy
- •Current smoker
- •History of alcoholism or a greater than recommended alcohol intake (>30 g of alcohol daily for men and >20 g of alcohol daily for women)
- •History of albumin allergy.
- •Pregnant or nursing mothers
- •History of severe claustrophobia
研究组 & 干预措施
High carbohydrate, low fat diet
65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein.
干预措施: Diet (Other)
High fat, low carbohydrate diet
65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein.
干预措施: Diet (Other)
结局指标
主要结局
Change in plasma triglyceride concentrations [mmol/L]
时间窗: Pre- and post-diet [21-28 days]
Change in plasma triglyceride concentrations in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.
次要结局
- Change in liver fat content [%](Pre- and post-diet [21-28 days])
- Change in the contribution of dietary and adipose tissue derived fatty acids to very low density lipoprotein-triglyceride (VLDL-TG) palmitate(Pre- and post-diet [21-28 days])
- Change in cardiac fat content [%](Pre- and post-diet [21-28 days])
- Change in hepatic fatty acid synthesis(Pre- and post-diet [21-28 days])
- Influence of genotype on the change in plasma lipid content [mmol/L](Pre- and post-diet [21-28 days])