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

Secondary Effects of Intermittent Fasting and Physical Exercise on the Modulation of the Gut Microbiota, Body Composition and Inflammatory Process in Obesity.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05237154
Enrollment
60
Registered
2022-02-11
Start date
2018-07-01
Completion date
2019-01-30
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Composition and Function of the Gut Microbiota Post Intervention, Metabolic and Inflammatory Variables Post Intervention

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

OTHERIntervention with intermittent fasting.

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).

OTHERIntervention with high-intensity interval training.

Intervention with high-intensity interval training, 3x per week, with intensity maintained between 70-85% of maximum heart rate.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Anthropometric changes (Body weight)eight weeksChanges in body weight (kilograms - Kg) pre and post intervention.
Anthropometric - height assessment (meters)eight weeksHeight measured in meters
Anthropometric changes (BMI)eight weeksChanges 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 weeksChanges in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Body composition changeseight weeksChanges in fat-free mass and fat mass evaluated pre and post intervention by whole-body air displacement plethysmography method, BodPod® .
Dietary intake changeseight weeksCompletion 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 assessmenteight weeksChanges in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Indirect calorimetry assessment (energetic substrates)eight weeksChanges in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry.
Changes in total cholesterol and lipid fractionseight weeksChanges 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 cytokineseight weeksChanges 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 balanceeight weeksDetermination 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 weeksQuantification 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 weeksTotal 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 performanceeight weeksPhysical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.
Changes in strength performanceeight weeksMaximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026