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

NCT ID: NCT05237154

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-01-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent fasting (IF)

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.

Group Type: EXPERIMENTAL

Intervention with intermittent fasting.

Intervention Type: OTHER

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).

Exercise: High-Intensity Interval Training (HIIT)

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.

Group Type: EXPERIMENTAL

Intervention with high-intensity interval training.

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

IF; HIIT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ellen Cristini de Freitas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Ribeirão Preto, São Paulo, Brazil

Gabriela Batitucci

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Batitucci G, Almeida OG, De Martinis ECP, Solar I, Cintra DE, de Freitas EC. Intermittent fasting and high-intensity interval training do not alter gut microbiota composition in adult women with obesity. Am J Physiol Endocrinol Metab. 2024 Sep 1;327(3):E241-E257. doi: 10.1152/ajpendo.00310.2023. Epub 2024 Jun 26.

Reference Type: DERIVED

PMID: 38922577 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35694163 (View on PubMed)

Other Identifiers

Gut Microbiota-Obesity

Identifier Type: -

Identifier Source: org_study_id