Secondary Effects of Intermittent Fasting and Physical Exercise on the Modulation of the Gut Microbiota, Body Composition and Inflammatory Process in Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Anthropometric changes (Body weight)
研究概览
简要总结
Obesity and overweight affect around 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity.
详细描述
Background: Obesity and overweight affect about 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity. Methods: 60 obese women will participate in the study and will be randomly divided into 3 groups: 1) the intermittent fasting group, submitted to a diet for 8 weeks (n= 20); 2) the physical exercise group, submitted to physical training for 8 weeks (n= 20); and 3) intermittent fasting group associated with physical exercise, submitted to both interventions for 8 weeks (n= 20). All volunteers will perform collections and evaluations (pre and post intervention) of anthropometry, food consumption, indirect calorimetry to assess resting energy expenditure, body composition by BodPod®, blood collection for biochemical analysis and gene expression, collection of feces for the analysis of the intestinal microbiota and physical tests (Shuttle Walking Test, multiple repetition test and functional strength) for the exercise groups. Expected results: The synergistic effects of the proposed intervention are expected to improve gut microbiota and metabolic parameters in obese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be randomly distributed into 3 groups: the intermittent fasting group (GIF) composed of individuals who will only perform the nutritional intervention for 8 weeks; the physical exercise group (GEX), composed of individuals who will perform only physical training for 8 weeks and the intermittent fasting group associated with physical exercise (GIF+EX), composed of individuals who will perform the nutritional intervention combined with physical training in the period of 8 weeks.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Individuals with any disease;
- •Alcoholics;
- •Use regular medication;
- •Medical impediment to the practice of physical activities;
- •Carry out nutritional monitoring;
- •Being in treatment for weight loss;
- •Present some discomfort in long periods of fasting.
结局指标
主要结局
Anthropometric changes (Body weight)
时间窗: eight weeks
Changes in body weight (kilograms - Kg) pre and post intervention.
Changes in total cholesterol and lipid fractions
时间窗: eight weeks
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c evaluated pre and post intervention, quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer.
Anthropometric - height assessment (meters)
时间窗: eight weeks
Height measured in meters
Anthropometric changes (BMI)
时间窗: eight weeks
Changes in body mass index (evaluated through a calculation that combines weight measured in kilograms divided by height in meters squared - BMI in kg/m\^2) evaluated pre and post intervention.
Body composition changes
时间窗: eight weeks
Changes in fat-free mass and fat mass evaluated pre and post intervention by whole-body air displacement plethysmography method, BodPod® .
Dietary intake changes
时间窗: eight weeks
Completion of the food record of three non-consecutive days, one day of the week that included the intermittent fasting protocol, another day of the week with ad libitum and a weekend day. This evaluation will take place pre-intervention, in the fourth week and after the intervention. Assessment of caloric intake, macronutrients and fiber evaluated pre and post intervention (Dietwin® software - São Paulo, Brazil).
Indirect calorimetry assessment
时间窗: eight weeks
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Indirect calorimetry assessment (energetic substrates)
时间窗: eight weeks
Changes in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry.
Changes in plasma cytokines
时间窗: eight weeks
Changes in serum levels of cytokines IL-15, IL-10, TNF-α adiponectin, resistin, adipsin/Factor D, fetuin-A and C-reactive protein evaluated pre and post intervention, by MILLIPLEX® Kit.
Changes in concentration of short-chain fatty acids (acetate, propionate, and butyrate)
时间窗: eight weeks
Quantification of short-chain fatty acids using stool samples, evaluated pre and post intervention, by gas chromatography method.
Changes in aerobic performance
时间窗: eight weeks
Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.
Anthropometric changes (Circumferences)
时间窗: eight weeks
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Changes in gut microbiota_Extraction and DNA sequencing and library preparation.
时间窗: eight weeks
Total fecal DNA extraction using the QIAamp 96 PowerFecal kit (Mobio-QIAGEN). Regions of interest V2-V3, V3-V4 and V4-V5 present in the extracted total DNA. Amplification and preparation of libraries according to the Illumina® kit protocol. 16S sequencing by Illumina® company's MiSeq platform. Metataxonomic analysis of 16S rDNA sequences by bioinformatics. Assessments analyzed pre and post intervention.
Changes in nitrogen balance
时间窗: eight weeks
Determination of urinary nitrogen by chemiluminescence method. 24-hour urine analysis evaluated pre and post intervention. Calculation of nitrogen balance by a equation.
Changes in strength performance
时间窗: eight weeks
Maximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press.
次要结局
未报告次要终点
研究者
Ellen Cristini de Freitas
Principal Investigator
University of Sao Paulo