Healthy MalesPerformanceNCT04756635
Effects of Short- Term Intermittent Fasting Aerobic and Anaerobic Capacity
A study testing Experimental Group in people with Healthy Males and Men, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males, Men
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 22 May 2018to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- All participants who do not meet the inclusion criteria mentioned above.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Joana Correia
Lisbon, 1499-002
Joana Correia, 911197842, joanacorreia-19@live.com.pt
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Males, Men
- Being tested
- Experimental Group
- Keywords
- Intermittent fasting, neuromuscular performance, aerobic capacity, anaerobic capacity
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Aerobic capacity, Anaerobic capacity, Neuromuscular performance
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Experimental Group |
| Control Group | Other | 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. Receives: Other: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Performance at 4 weeks
Neuromuscular performance, aerobic and anaerobic capacity
Measured: 4weeks (experiemental) + 4weeks (control)
Secondary outcomes (1)
Change from Baseline Body Composition at 4 weeks
Fat Free Mass (kilograms), Fat Mass (kilograms), Body Mass Index (kg/m^2), Body Weight (kilograms)
Measured: 4weeks (experiemental) + 4weeks (control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start22 May 2018
- Primary completion12 Apr 2021
- Study completion5 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joana Correia, Faculdade de Motricidade Humana
- Investigators
- Joana M. Correia, Master, Principal investigator, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756635
- Sponsor's protocol ID
- joana_correia
- Acronym
- Performance
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public articles with no reference to participants
Publications
Correia JM, Pezarat-Correia P, Minderico C, Infante J, Mendonca GV. Effects of Time-Restricted Eating on Aerobic Capacity, Body Composition, and Markers of Metabolic Health in Healthy Male Recreational Runners: A Randomized Crossover Trial. J Acad Nutr Diet. 2024 Aug;124(8):1041-1050. doi: 10.1016/j.jand.2024.01.005. Epub 2024 Jan 17.
PubMed 38242204
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short- Term Intermittent Fasting on Neuromuscular Performance, Aerobic and Anaerobic Capacity
- ClinicalTrials.gov ID
- NCT04756635
- Acronym / sponsor ID
- Performance / joana_correia
- Conditions
- Healthy Males, Men
- Keywords
- Intermittent fasting, neuromuscular performance, aerobic capacity, anaerobic capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 5 Feb 2023 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Experimental GroupMeasures 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. |
| Control Group | Other | Other: Experimental GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- All participants who do not meet the inclusion criteria mentioned above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: Aerobic capacity, Anaerobic capacity, Neuromuscular performanceThis 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 | Control Group, Experimental Group |
Primary outcome
Change from Baseline Performance at 4 weeks
Time frame: 4weeks (experiemental) + 4weeks (control)
Neuromuscular performance, aerobic and anaerobic capacity
1 secondary outcome
Change from Baseline Body Composition at 4 weeks
Time frame: 4weeks (experiemental) + 4weeks (control)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 38242204Correia JM, Pezarat-Correia P, Minderico C, Infante J, Mendonca GV. Effects of Time-Restricted Eating on Aerobic Capacity, Body Composition, and Markers of Metabolic Health in Healthy Male Recreational Runners: A Randomized Crossover Trial. J Acad Nutr Diet. 2024 Aug;124(8):1041-1050. doi: 10.1016/j.jand.2024.01.005. Epub 2024 Jan 17.
- Individual participant dataSharing planned: Yes. Public articles with no reference to participants
Related trials for Healthy Males
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana M. Correia, Master principal investigator
Faculdade de Motricidade Humana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Healthy Males and Men, run by Faculdade de Motricidade Humana at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joana M. Correia, Master (911197842, joanacorreia-19@live.com.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Performance at 4 weeks (time frame: 4weeks (experiemental) + 4weeks (control)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.