Intermittent Fasting and Exercise: Effects on Gut Microbiota, Body Composition and Inflammation.

Not Applicable

Completed

• Conditions: Composition and Function of the Gut Microbiota Post Intervention; Metabolic and Inflammatory Variables Post Intervention
• Interventions: Other: Intervention with high-intensity interval training.; Other: Intervention with intermittent fasting.

• Registration Number: NCT05237154
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2018-12-15
• Study Completion: 2019-01-30
• Study First Submitted: 2022-01-20
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise: High-Intensity Interval Training (HIIT)	Intervention with high-intensity interval training.	High intensity circuit training. Progressive training protocol 3x/week, for 8 weeks, with at least 1 day of rest between sessions and duration of 25 minutes each session - 4 minutes of initial warm-up, 18 minutes of the main part and 3 minutes of relaxation. First and second week: 30 second run and recovery time. Third and fourth week: 35-second runtime and 25-second recovery time. Fifth and Sixth Week: 40-second runtime and 20-second recovery time. Seventh and eighth weeks: 45-second runtime and 15-second recovery time.
Intermittent fasting (IF)	Intervention with intermittent fasting.	Alternate-day intermittent fasting. Consumption of 25% of daily energy requirements on scheduled fasting days involving energy restriction for 2 non-consecutive days of the week and ad libitum feeding on the other 5 days of the week. Period: 8 weeks.

Primary Outcome Measures

Name	Time	Method
Anthropometric changes (Body weight)	eight weeks	Changes in body weight (kilograms - Kg) pre and post intervention.
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.
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.
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 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 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 aerobic performance	eight weeks	Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.
Anthropometric changes (Circumferences)	eight weeks	Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
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 strength performance	eight weeks	Strength endurance capacity by 1-minute functional tests (squat, free squat and push-up).
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.

Trial Locations

Locations (2)

Gabriela Batitucci; 🇧🇷 Ribeirão Preto, SP, Brazil

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.; 🇧🇷 Ribeirão Preto, São Paulo, Brazil