Clinical trial NCT05237154: Intermittent Fasting and Exercise: Effects on Gut Microbiota, Body Composition and Inflammation.
Official title: Secondary Effects of Intermittent Fasting and Physical Exercise on the Modulation of the Gut Microbiota, Body Composition and Inflammatory Process in Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2022-02-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometric changes (Body weight)
timeFrame: eight weeks
measure: Anthropometric - height assessment (meters)
timeFrame: eight weeks
measure: Anthropometric changes (BMI)
timeFrame: eight weeks
measure: Anthropometric changes (Circumferences)
timeFrame: eight weeks
measure: Body composition changes
timeFrame: eight weeks
measure: Dietary intake changes
timeFrame: eight weeks
measure: Indirect calorimetry assessment
timeFrame: eight weeks
measure: Indirect calorimetry assessment (energetic substrates)
timeFrame: eight weeks
measure: Changes in total cholesterol and lipid fractions
timeFrame: eight weeks
measure: Changes in plasma cytokines
timeFrame: eight weeks
measure: Changes in nitrogen balance
timeFrame: eight weeks
measure: Changes in concentration of short-chain fatty acids (acetate, propionate, and butyrate)
timeFrame: eight weeks
measure: Changes in gut microbiota_Extraction and DNA sequencing and library preparation.
timeFrame: eight weeks
measure: Changes in aerobic performance
timeFrame: eight weeks
measure: Changes in strength performance
timeFrame: eight weeks
measure: Changes in strength performance
timeFrame: eight weeks
measure: Changes in strength performance
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Gabriela Batitucci
state: SP
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
state: São Paulo
Study officials:
References:
citation: Batitucci G, Faria Junior EV, Nogueira JE, Brandao CFC, Abud GF, Ortiz GU, Marchini JS, Freitas EC. Impact of Intermittent Fasting Combined With High-Intensity Interval Training on Body Composition, Metabolic Biomarkers, and Physical Fitness in Women With Obesity. Front Nutr. 2022 May 26;9:884305. doi: 10.3389/fnut.2022.884305. eCollection 2022.