Effect of Fasting Mimicking Diet on the Activation of Beige/Brown Adipose Tissue in Humans
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Activation of beige/brown adipose tissue - Volume
研究概览
简要总结
Obesity today has become one of the main public health concerns. As a consequence, different strategies have arisen to fight weight gain. One of the alternative strategies to increase the success of therapeutic approaches to weight loss is the increase in energy expenditure, through thermogenesis, regulated by the beige/brown adipose tissue (BAT). Studies have shown that beige/BAT has a strong correlation with body weight regulation. It has also been demonstrated that cold exposure activates beige/BAT. Recent studies, mainly in animal models, suggest that beige/BAT can also be activated by specific food and nutrients. Concomitantly, new dietary interventions, to treat obesity, have also been studied. One of these dietary interventions is the Fasting Mimicking Diet (FMD). Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT. The aim of this is study is to investigate the effect of Fasting Mimicking Diet on the activation of beige/brown adipose tissue, in humans with overweight. This will be an open clinical trial with the duration of three consecutive months (three cycles of the FMD diet). There will be an FMD and a control group. The following data will be collected before and after the intervention, for each group: dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation (Positron Emission Tomography - PET with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with computed tomography - PET/CT scan, Thermal Imaging, BAT adipokines and genes related to BAT activity), basal metabolic rates and caloric needs (Indirect Calorimetry), anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. Data will be expressed as mean and standard deviation and the variables will be compared by Student's t-test or ANOVA, for repeated measures.
详细描述
HYPOTHESIS
Beige/BAT has been shown as a promising strategy to treat obesity. The exact mechanism, and stimulus, of activation of this tissue have not been completely clarified. However, some studies have identified some nutrients, such as unsaturated fat, as a potential stimulus for activation. The effect of Fasting Mimicking Diet on the activation of Beige/Brown Adipose Tissue has not yet been investigated. Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT.
Our hypothesis is that an intervention, with a 5-days cycle for 3 consecutive months, of Fasting Mimicking Diet will promote beige/brown adipose tissue activation and will improve body weight and metabolic markers related to obesity, in humans with overweight.
OBJECTIVES
Main Objective
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 25 and < 30kg/m2.
排除标准
- •Residing outside of Campinas county;
- •Pregnant or lactating women;
- •Patients with severe, non-stabilized neurological or psychiatric problems;
- •Use of anti-obesity or lipid-lowering medication;
- •Use of adrenergic or benzodiazepine drugs;
- •Use of illicit drugs;
- •Individuals with neoplasms, transmissible diseases, rheumatic disease, hepatic or renal insufficiency, non-treated thyroid dysfunction, diabetes mellitus, cardiovascular disease, history of fainting, active infection;
- •Individuals who are allergic to nuts, soybean, oats, sesame or celery;
- •Individuals who have had a change of more than 5% of their body weight in the last six months;
- •Individuals who are carrying some kind of diet or modification to their habitual eating habits.
研究组 & 干预措施
FMD Group
Participants will be requested to follow a Fasting Mimicking Diet, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers.
干预措施: Fasting Mimicking Diet (Other)
Control Group
Participants will be requested to continue with their habitual eating habits, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers.
结局指标
主要结局
Activation of beige/brown adipose tissue - Volume
时间窗: Three months
Changes from baseline maximum Standardized Uptake Values (SUVmax) and mean Standardized Uptake Values (SUVmean), as assessed by PET/CT (FDG-18).
Activation of beige/brown adipose tissue - Activation Genes
时间窗: Three months
Changes from baseline BAT activation genes, as assessed by PCR.
Activation of beige/brown adipose tissue - Temperature
时间窗: Three months
Changes from baseline BAT temperature, as assessed by Thermal Imaging.
Activation of beige/brown adipose tissue - Adipokines
时间窗: Three months
Changes from baseline BAT adipokines, as assessed by ELISA.
次要结局
- Hormones(Three months)
- Basal metabolic rates (BMR)(Three months)
- Inflammatory markers(Three months)
- Insulin Sensitivity(Three months)
- Metabolic markers(Three months)
研究者
Marcela Reymond Simoes
Principal Investigator
University of Campinas, Brazil