Effects of Short- Term Intermittent Fasting Aerobic and Anaerobic Capacity (Performance)

July 25, 2022 updated by: Joana Correia, Faculdade de Motricidade Humana

Effects of Short- Term Intermittent Fasting on Neuromuscular Performance, Aerobic and Anaerobic Capacity

The therapeutic use of caloric restriction and intermittent fasting (IF) protocols improves life span and health related quality of life. The effects of fasting protocols on athletic performance and training adaptations have been primarily studied in athletes undergoing the Ramadan IF protocol or in athletes willing to decrease body fat, while maintaining or increasing lean body mass. Data from these studies are somewhat conflicting and unclear. Moreover, the effects of IF on muscular strength, as well as in aerobic and anaerobic capacity remain largely unknown. Anecdotal evidence from experienced participants in strength, power and endurance training or sports, indicates an increased ability to acutely display higher levels of work capacity in the fasted vs. fed state. The goal of this project is to determine the effects of 4 wks of IF on neuromuscular performance, aerobic and anaerobic capacity of well-trained young adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This 3-year project will include two groups of participants: 1) young men accustomed to resistance training (study #1) and 2) young men accustomed to endurance training (study #2). Inclusion will be limited to healthy participants (i.e. nonsmokers, normotensive with systolic and diastolic values <135/85 mmHg, non-obese, non-medicated, and free of any known disease as assessed by medical history) (Pickering, Hall et al. 2005). Month 1-3 will focus on literature review and month 4 to 8 will address experimental settings preparation and selection of participants to include in each study. Testing and data collection will be scheduled for months 9-14 and 13-18 (study # 1 and 2 related testing, respectively). Data processing, analysis and presentation will occur from month 21 to 33. All participants will read and sign an informed consent document with the description of the testing procedures. The Faculty's ethical committee will be asked to approve this document before testing. All studies will follow a randomized crossover design, with measures taken before and after the defined IF periods and participants of each group serving as their own controls. Two groups of participants will be included in this project: 1) group #1: resistance trained group (tested for neuromuscular function, anaerobic capacity and body composition); 2) group #2: endurance trained group (tested for aerobic and anaerobic capacity and body composition). In a randomized, counterbalanced manner, all participants will be tested in two different conditions: control condition (pre- and post4 wks of normal diet) vs. experimental condition (pre- and post-4 wks of IF). A 2-wk washout period will separate both conditions. Measurements will be taken during the morning period (between 07:00 and 11:00 am) in the fasted state. Neuromuscular function and anaerobic capacity will be assessed on separate days (with at least a 48- hour interval) to ensure full recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Inclusion will be limited to young, healthy men with aged 20- 30 years. All participants will exhibit > 3 years of continued experience and current participation in strength and power sports/training (training frequency of at least 3 times/wk). As importantly, the following criteria will also be determinant for inclusion: 1) bench press one-repetition maximum/bodyweight ratio > 1.26 (i.e. above the 80 percentile for 20 to 29-year-old males) (ACSM 2013) and 2) leg press one-repetition maximum /bodyweight ratio > 2.08 (i.e. above the 80 percentile for 20 to 29-year-old males) (ACSM 2013). Finally, for inclusion, all participants will have to follow the nutritional and training recommendations at pre-testing time point.
  • For study 2, as for study 1, Inclusion will be limited to young, healthy men with aged 20- 30 yrs. All participants will exhibit > 3 yrs of continued experience and current participation in endurance based sports/training (training frequency of at least 3 times/wk). We will only include participants with VO2peak values > 49 mL.kg-1.min-1(i.e. above the 80 percentile for 20 to 29-year-old males) (ACSM 2013). Finally, for inclusion, all participants will have to follow the nutritional and training recommendations at pre-testing time point.

Exclusion Criteria:

  • All participants who do not meet the inclusion criteria mentioned above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Measures taken before and after the defined IF periods. Two groups of participants will be included in this project: 1) resistance trained group (tested for neuromuscular function, anaerobic capacity and body composition); 2) endurance trained group (tested for aerobic and anaerobic capacity and body composition). Experimental condition: pre- and post-4 weeks of IF. Measurements will be taken during the morning period (between 07:00 and 11:00 am) in the fasted state. Neuromuscular function and anaerobic capacity will be assessed on separate days (with at least a 48- hour interval) to ensure full recovery.
Other: Experimental Group
This 3-year project will include two groups of participants: 1) young men accustomed to resistance training (study #1) and 2) young men accustomed to endurance training (study #2). Inclusion will be limited to healthy participants (i.e. nonsmokers, normotensive with systolic and diastolic values <135/85 mmHg, non-obese, non-medicated, and free of any known disease as assessed by medical history) (Pickering, Hall et al. 2005). Month 1-3 will focus on literature review and month 4 to 8 will address experimental settings preparation and selection of participants to include in each study. Testing and data collection will be scheduled for months 9-14 and 13-18 (study # 1 and 2 related testing, respectively). Data processing, analysis and presentation will occur from month 21 to 33. All participants will read and sign an informed consent document with the description of the testing procedures. The Faculty's ethical committee will be asked to approve this document before testing.
Other Names:
  • Aerobic capacity
  • Anaerobic capacity
  • Neuromuscular performance
Other: Control Group
Participants of each group serving as their own controls. Control condition: pre- and post4 weeks of normal diet. Measurements will be taken during the morning period (between 07:00 and 11:00 am) in the fasted state. Neuromuscular function and anaerobic capacity will be assessed on separate days (with at least a 48-hour interval) to ensure full recovery.
Other: Experimental Group
This 3-year project will include two groups of participants: 1) young men accustomed to resistance training (study #1) and 2) young men accustomed to endurance training (study #2). Inclusion will be limited to healthy participants (i.e. nonsmokers, normotensive with systolic and diastolic values <135/85 mmHg, non-obese, non-medicated, and free of any known disease as assessed by medical history) (Pickering, Hall et al. 2005). Month 1-3 will focus on literature review and month 4 to 8 will address experimental settings preparation and selection of participants to include in each study. Testing and data collection will be scheduled for months 9-14 and 13-18 (study # 1 and 2 related testing, respectively). Data processing, analysis and presentation will occur from month 21 to 33. All participants will read and sign an informed consent document with the description of the testing procedures. The Faculty's ethical committee will be asked to approve this document before testing.
Other Names:
  • Aerobic capacity
  • Anaerobic capacity
  • Neuromuscular performance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Performance at 4 weeks
Time Frame: 4weeks (experiemental) + 4weeks (control)
Neuromuscular performance, aerobic and anaerobic capacity
4weeks (experiemental) + 4weeks (control)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Body Composition at 4 weeks
Time Frame: 4weeks (experiemental) + 4weeks (control)
Fat Free Mass (kilograms), Fat Mass (kilograms), Body Mass Index (kg/m^2), Body Weight (kilograms)
4weeks (experiemental) + 4weeks (control)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculdade de Motricidade Humana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joana M. Correia, Master, Faculdade de Motricidade Humana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • joana_correia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Public articles with no reference to participants

IPD Sharing Time Frame

The data will be stored in an SPSS and excel database, on the server of the Faculty of Human Motricity assigned to the Motor Behavior Laboratory. Paper-based documents will be destroyed after the data processing matrix is built.

IPD Sharing Access Criteria

Public articles with no reference to participants

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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