- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756635
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
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
Interventional
Enrollment (Anticipated)
50
Phase
- 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
- Name: Joana M. Correia, Master
- Phone Number: 911197842
- Email: joanacorreia-19@live.com.pt
Study Locations
-
-
-
Lisboa, Portugal, 1499-002
- Recruiting
- Joana Correia
-
Contact:
- Joana Correia
- Phone Number: 911197842
- Email: joanacorreia-19@live.com.pt
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
May 22, 2018
Primary Completion (Actual)
April 12, 2021
Study Completion (Anticipated)
February 5, 2023
Study Registration Dates
First Submitted
February 12, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (Actual)
February 16, 2021
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID 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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