Effect of Monounsaturated Fatty Acids Consumption in Brown/Beige Adipose Tissue Activity in Human Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV)
研究概览
简要总结
Considering the high prevalence of obesity its comorbidities in Brazil and in the world, different therapeutic measures have been suggested. It is currently known that brown/beige adipose tissue plays an important role in body weight control and there is strong evidence that its activity is inversely associated with obesity and metabolic diseases. Recent studies have shown an important role foods and nutrients in the activation of brown/beige adipose tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to metabolism have been described in several studies, however, the effects of consuming large amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been explored. The aim of the study is to evaluate the impact of the consumption of large amounts of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls (normal weight) participants will undergo a dietary intervention for 4 weeks with extra virgin olive oil. Before and after the intervention period several data will be collected: dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with 18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging - PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and standard deviation and the variables compared by the Student t test or ANOVA for repeated measures.
详细描述
- HYPOTHESIS The effects of fatty acids consumption on brown / beige adipose tissue have not yet been explored in humans. However, studies that evaluated the effects of saturated fatty acid replacement by monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs) on animal and human models have observed an improvement in cardiovascular risk factors, such as reduction of subclinical inflammation, improvement of lipid profile and increase in insulin sensitivity. The mechanisms by which these fatty acids act in the improvement of risk factors have not been completely clarified and it is possible that there is an association between the reduction of cardiovascular risk factors and the activation of brown / beige adipose tissue.
Our hypothesis is that consuming extra virgin olive oil in high amounts for one month will promote increased brown adipose tissue (BAT) activity of the participants and improve the cardiovascular risk profile, as assessed by inflammatory markers. It is possible that the response of lean and obese subjects to dietary intervention is different and that the behavior of BAT is not equal in both groups. 2. OBJECTIVE To evaluate the impact of the consumption of large amounts of extra virgin olive oil (source of monounsaturated fatty acids) on the activity of brown / beige adipose tissue in lean and obese humans.
2.1 Specific objectives • To investigate the activity of brown and beige adipose tissue by FDG PET / RMI, before and after four weeks of intervention with high amount of extra virgin olive oil; • To evaluate the expression of BAT activity markers: uncoupling protein 1 (UCP-1), PR domain containing 16 (PRDM16), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), iodothyronine deiodinase 2 (Dio2) in mononuclear cells in the whole sample;
- To evaluate levels of fatty acids in the blood by gas chromatography, before and after the intervention to evaluate changes in fatty acid intake;
- To evaluate concentrations of pro and anti-inflammatory cytokines in the blood before and after 4 weeks of intervention: tumor necrosis factor alpha (TNF-α), interleukin 1-beta (IL1β), Monocyte Chemoattractant Protein-1 (MCP-1), interleukin-6 and interleukin-10);
- To evaluate the effects of interventions on metabolic markers before and after the intervention: leptin, insulin, glucose, total cholesterol and fractions, triglycerides;
- To evaluate the effects of the intervention on anthropometry (weight, abdominal circumference) and on the body composition evaluated by Dual-energy X-ray absorptiometry (DXA);
- To evaluate the effects of dietary interventions on brain activity (by PET/MRi) in a subsample of 15 individuals.
- MATERIALS AND METHODS This will be an open clinical trial lasting for four weeks. The study consists of two data collections before and after a 4-week dietary intervention in which participants will be required to consume extra-virgin olive oil provided by the researchers.
The collection of socio demographic, dietary and physical activity data, as well as the PET / MRI and the blood collections of 50 participants will be carried out at the Nuclear Medicine Center of the Medical School of the University of São Paulo. Bone densitometry (DXA) will be performed at the School of Public Health of the University of São Paulo.
Selection of participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: Both Age: 25 to 40 years
- •Body mass index (BMI):
- •Normal body weight group: BMI lower than 25 kg/m2 Obese group: BMI between 30 and 35 kg/m2
排除标准
- •Living outside of São Paulo;
- •pregnant women;
- •patients with severe or non-stabilized neurological or psychiatric problems;
- •use of anti-obesity or lipid-lowering medication;
- •use of adrenergic or benzodiazepine drugs;
- •individuals with neoplasms, transmissible and rheumatic diseases, hepatic or renal insufficiency, untreated thyroid dysfunction; Diabetes mellitus;
- •individuals that changed more than 5% of body weight in the last six months; 8) to be carrying out some kind of diet or modification in the usual dietary pattern; 9) having metal prostheses.
结局指标
主要结局
Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV)
时间窗: Four weeks
We will investigate whether 4 weeks of olive oil consumption can increase the activity of brown adipose tissue measured by mean standardized disposal value (volume) using magnetic resonance imaging
次要结局
- Hypothalamic inflammation(Four weeks)
- Lipid profile(Four weeks)
- Inflammatory markers(Four weeks)
研究者
Milena Monfort Pires
LDN, MSc, PhD
University of Campinas, Brazil