Composition and Function of the Gut Microbiota Post Intervention, Metabolic and Inflammatory Variables Post Intervention
Conditions
Keywords
Obesity, Gut microbiota, Intermittent fasting, High-intensity interval training, Metataxononic, Body composition
Brief summary
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.
Detailed description
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.
Interventions
Intervention with fasting protocol of alternate days 2 days a week and the other days with ad libitum consumption. Restricted food in 25% of the total daily needs on the days of the intermittent fasting protocol, with 18 hours of fasting and 6 hours of restricted feeding (18:6).
Intervention with high-intensity interval training, 3x per week, with intensity maintained between 70-85% of maximum heart rate.
Sponsors
Study design
Masking description
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.
Intervention model description
Randomized clinical trial.
Eligibility
Inclusion criteria
* Age between 18 and 40 years; * Women; * Have a regular menstrual cycle; * Body weight below 120 kg; * BMI between 30 kg/m2 and 40 kg/m2.
Exclusion criteria
* Individuals with any disease; * Smokers; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric changes (Body weight) | eight weeks | Changes in body weight (kilograms - Kg) pre and post intervention. |
| Anthropometric - height assessment (meters) | eight weeks | Height measured in meters |
| Anthropometric changes (BMI) | 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. |
| Anthropometric changes (Circumferences) | eight weeks | Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention. |
| Body composition changes | 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 | 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 | eight weeks | Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry. |
| Indirect calorimetry assessment (energetic substrates) | eight weeks | Changes in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry. |
| Changes in total cholesterol and lipid fractions | 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. |
| Changes in plasma cytokines | 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 nitrogen balance | 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 concentration of short-chain fatty acids (acetate, propionate, and butyrate) | eight weeks | Quantification of short-chain fatty acids using stool samples, evaluated pre and post intervention, by gas chromatography method. |
| Changes in gut microbiota_Extraction and DNA sequencing and library preparation. | 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 aerobic performance | eight weeks | Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking. |
| Changes in strength performance | eight weeks | Maximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press. |
Countries
Brazil