Body CompositionNCT04404413
High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
A study testing Intensity interval training (HIIT) and Intensity interval training (HIIT) + intermittent fasting in people with Body Composition and Physical Performance, run by University of Alicante at 1 site in Spain.
Trial summary
The objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Physical Performance, Intermittent Fasting
- What is being tested?
- Intensity interval training (HIIT) and Intensity interval training (HIIT) + intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 1 Mar 2020
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.
- Not to present cardiovascular or cardiorespiratory problems.
- Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.
Who cannot join
- Following pharmacological treatment or supplement.
- Performing other sports activities that may influence the study results during their participation in the study.
- Not following training or diet program guidelines or attending scheduled training sessions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Alejandro Martínez Rodriguez
San Vicent del Raspeig, Alicante, 03690
About this study
Official title: Effect of High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
The objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance (Hand-grip strength, Counter movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in between both phases when they did not perform the scheduled activity, so as not to alter the experimental phase.
- Conditions
- Body Composition, Physical Performance, Intermittent Fasting
- Being tested
- Intensity interval training (HIIT), Intensity interval training (HIIT) + intermittent fasting
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity interval training (HIIT)Behavioural
2x8 weeks of high-intensity interval training (HIIT)
Intensity interval training (HIIT) + intermittent fastingBehavioural
2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).
| Study group | Role | What they receive |
|---|---|---|
| PARTICIPANTS | Experimental | A single-group crossover design was used to compare the effects of 2x8 weeks of high-intensity interval training without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance. There were two weeks in the middle of both phases in which they did not carry out programmed activity, in order not to alter the experimental phase. Receives: Behavioral: Intensity interval training (HIIT); Behavioral: Intensity interval training (HIIT) + intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-grip strength
Hand-grip strength test was performed as an indicator of overall strength.
Measured: 16 weeks
Counter movement jump (CMJ)
In the CMJ test, the participants performed a maximum vertical jump starting from a standing position with arm swing not allowed.
Measured: 16 weeks
Wingate Anaerobic 30 s Cycling Test
Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden).
Measured: 16 weeks
Fat mass
Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass.
Measured: 16 weeks
Muscle mass
Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass.
Measured: 16 weeks
Residual mass
Body composition masses were estimated using validated equations. Residual mass was obtained from the difference between fat mass and muscle mass.
Measured: 16 weeks
Body Mass
It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Sep 2019
- Primary completion11 Sep 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404413
- Sponsor's protocol ID
- CE061811
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women
- ClinicalTrials.gov ID
- NCT04404413
- Acronym / sponsor ID
- CE061811
- Conditions
- Body Composition, Physical Performance, Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 May 2020 (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 objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance (Hand-grip strength, Counter movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in between both phases when they did not perform the scheduled activity, so as not to alter the experimental phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PARTICIPANTS | Experimental | Behavioral: Intensity interval training (HIIT), Behavioral: Intensity interval training (HIIT) + intermittent fastingA single-group crossover design was used to compare the effects of 2x8 weeks of high-intensity interval training without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance. There were two weeks in the middle of both phases in which they did not carry out programmed activity, in order not to alter the experimental phase. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.
- Not to present cardiovascular or cardiorespiratory problems.
- Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.
Key exclusion criteria (3 listed)
- Following pharmacological treatment or supplement.
- Performing other sports activities that may influence the study results during their participation in the study.
- Not following training or diet program guidelines or attending scheduled training sessions.
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 |
|---|---|---|
| Intensity interval training (HIIT)2x8 weeks of high-intensity interval training (HIIT) | Behavioural | PARTICIPANTS |
| Intensity interval training (HIIT) + intermittent fasting2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake). | Behavioural | PARTICIPANTS |
Primary outcome
Hand-grip strength
Time frame: 16 weeks
Hand-grip strength test was performed as an indicator of overall strength.
Counter movement jump (CMJ)
Time frame: 16 weeks
In the CMJ test, the participants performed a maximum vertical jump starting from a standing position with arm swing not allowed.
Wingate Anaerobic 30 s Cycling Test
Time frame: 16 weeks
Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden).
Fat mass
Time frame: 16 weeks
Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass.
Muscle mass
Time frame: 16 weeks
Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass.
Residual mass
Time frame: 16 weeks
Body composition masses were estimated using validated equations. Residual mass was obtained from the difference between fat mass and muscle mass.
Body Mass
Time frame: 16 weeks
It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity interval training (HIIT) and Intensity interval training (HIIT) + intermittent fasting in people with Body Composition and Physical Performance, run by University of Alicante at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 May 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-grip strength (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.