NCT05237154

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-12-15
• Completion: 2019-01-30
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

2 sites across 1 country: Brazil