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

NCT05237154 | Completed

• 1 other identifier: Gut Microbiota-Obesity
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (17)

• Anthropometric changes (Body weight)

  Changes in body weight (kilograms - Kg) pre and post intervention.

  eight weeks

• Anthropometric - height assessment (meters)

  Height measured in meters

  eight weeks

• Anthropometric changes (BMI)

  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.

  eight weeks

• Anthropometric changes (Circumferences)

  Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.

  eight weeks

• Body composition changes

  Changes in fat-free mass and fat mass evaluated pre and post intervention by whole-body air displacement plethysmography method, BodPod® .

  eight weeks

• Dietary intake changes

  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).

  eight weeks

• Indirect calorimetry assessment

  Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.

  eight weeks

• Indirect calorimetry assessment (energetic substrates)

  Changes in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry.

  eight weeks

• Changes in total cholesterol and lipid fractions

  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.

  eight weeks

• Changes in plasma cytokines

  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.

  eight weeks

• Changes in nitrogen balance

  Determination of urinary nitrogen by chemiluminescence method. 24-hour urine analysis evaluated pre and post intervention. Calculation of nitrogen balance by a equation.

  eight weeks

• Changes in concentration of short-chain fatty acids (acetate, propionate, and butyrate)

  Quantification of short-chain fatty acids using stool samples, evaluated pre and post intervention, by gas chromatography method.

  eight weeks

• Changes in gut microbiota_Extraction and DNA sequencing and library preparation.

  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.

  eight weeks

• Changes in aerobic performance

  Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.

  eight weeks

• Changes in strength performance

  Maximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press.

  eight weeks

• Changes in strength performance

  Assessment of changes in maximal isometric muscle strength of the dorsal region and handgrip by dynamometry.

  eight weeks

• Changes in strength performance

  Strength endurance capacity by 1-minute functional tests (squat, free squat and push-up).

  eight weeks

Study Arms (2)

Intermittent fasting (IF)

EXPERIMENTAL

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.

Other: Intervention with intermittent fasting.

Exercise: High-Intensity Interval Training (HIIT)

EXPERIMENTAL

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.

Other: Intervention with high-intensity interval training.

Interventions

Intervention with intermittent fasting. 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).

Also known as: IF

Intermittent fasting (IF)

Intervention with high-intensity interval training. OTHER

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

Also known as: HIIT

Exercise: High-Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (2)

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Gabriela Batitucci

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (2)

• 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.

  PMID: 38922577 DERIVED

• 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.

  PMID: 35694163 DERIVED

MeSH Terms

Conditions

Obesity; Intermittent Fasting

Interventions

Methods; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 11, 2022
• Study Start: July 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 30, 2019
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)