ObesityHIIT-FASTNCT03236285
Microvascular and Metabolic Effects of High-intensity Interval Exercise Training
A study testing High-intensity interval exercise training in the fed state, Continous exercise training in the fed state and High-intensity interval exercise training in the fasting state in people with Obesity and Overweight, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Physical Activity
- What is being tested?
- High-intensity interval exercise training in the fed state, Continous exercise training in the fed state and High-intensity interval exercise training in the fasting state
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2018to Oct 2021
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female gender
- Age≥ 30 years and ≤50 years
- Premenopausal status
- Body mass index >25 kg/m2
- At least one of the following:
- waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol <50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl
Who cannot join
- Any cardiovascular disease, including systemic hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
- Orthopedic or neurologic conditions that might impair exercise training
- Pregnancy or breastfeeding
- Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
- Current engagement in any exercise training protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, 22240-006
About this study
Official title: Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial
The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.
Read the detailed description
Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.
Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.
- Conditions
- Obesity, Overweight, Physical Activity
- Being tested
- High-intensity interval exercise training in the fed state, Continous exercise training in the fed state, High-intensity interval exercise training in the fasting state, Continous exercise training in the fasting state
- Keywords
- Obesity, Microcirculation, Endothelial function, Laser speckle imaging, Capillary density
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval exercise training in the fed stateBehavioural
High-intensity interval exercise training in the fed state
Continous exercise training in the fed stateBehavioural
Continous exercise training in the fed state
High-intensity interval exercise training in the fasting stateBehavioural
High-intensity interval exercise training in the fasting state
Continous exercise training in the fasting stateBehavioural
Continous exercise training in the fasting state
| Study group | Role | What they receive |
|---|---|---|
| HIIT only | Experimental | Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state Receives: Behavioral: High-intensity interval exercise training in the fed state |
| CT+FAST | Experimental | Volunteers will be submitted to continous training (CT) performed in the fasting state Receives: Behavioral: Continous exercise training in the fasting state |
| CT only | Experimental | Volunteers will be submitted to continous training (CT) performed in fed state. Receives: Behavioral: Continous exercise training in the fed state |
| HIIT+FAST | Experimental | Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state. Receives: Behavioral: High-intensity interval exercise training in the fasting state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary density
Number of spontaneously perfused skin capillaries per mm2
Measured: 6 months
Secondary outcomes (1)
Microvascular reactivity assessed by laser speckle contrast imaging
Skin microvascular flow in arbitrary perfusion units
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start20 Feb 2018
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Facilities for the exercise training program were not available for the study.
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 ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
- Investigators
- EDUARDO V TIBIRICA, MD, PhD, Principal investigator, National Innstitute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236285
- Sponsor's protocol ID
- CAAE:69240017.1.0000.5272
- Acronym
- HIIT-FAST
- Status last verified
- Mar 2019
- First submitted
- 27 Jul 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Lorenzo A, Van Bavel D, de Moraes R, Tibirica EV. High-intensity interval training or continuous training, combined or not with fasting, in obese or overweight women with cardiometabolic risk factors: study protocol for a randomised clinical trial. BMJ Open. 2018 Apr 28;8(4):e019304. doi: 10.1136/bmjopen-2017-019304.
PubMed 29705753
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03236285
- Acronym / sponsor ID
- HIIT-FAST / CAAE:69240017.1.0000.5272
- Conditions
- Obesity, Overweight, Physical Activity
- Keywords
- Obesity, Microcirculation, Endothelial function, Laser speckle imaging, Capillary density
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Facilities for the exercise training program were not available for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 1 Aug 2017 (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 study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.
Detailed description
Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.
Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIIT only | Experimental | Behavioral: High-intensity interval exercise training in the fed stateVolunteers will be submitted to high-intensity interval training (HIIT) performed in fed state |
| CT+FAST | Experimental | Behavioral: Continous exercise training in the fasting stateVolunteers will be submitted to continous training (CT) performed in the fasting state |
| CT only | Experimental | Behavioral: Continous exercise training in the fed stateVolunteers will be submitted to continous training (CT) performed in fed state. |
| HIIT+FAST | Experimental | Behavioral: High-intensity interval exercise training in the fasting stateVolunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female gender
- Age≥ 30 years and ≤50 years
- Premenopausal status
- Body mass index >25 kg/m2
- At least one of the following:
Key exclusion criteria (8 listed)
- Any cardiovascular disease, including systemic hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
- Orthopedic or neurologic conditions that might impair exercise training
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 |
|---|---|---|
| High-intensity interval exercise training in the fed stateHigh-intensity interval exercise training in the fed state | Behavioural | HIIT only |
| Continous exercise training in the fed stateContinous exercise training in the fed state | Behavioural | CT only |
| High-intensity interval exercise training in the fasting stateHigh-intensity interval exercise training in the fasting state | Behavioural | HIIT+FAST |
| Continous exercise training in the fasting stateContinous exercise training in the fasting state | Behavioural | CT+FAST |
Primary outcome
Capillary density
Time frame: 6 months
Number of spontaneously perfused skin capillaries per mm2
1 secondary outcome
Microvascular reactivity assessed by laser speckle contrast imaging
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 29705753De Lorenzo A, Van Bavel D, de Moraes R, Tibirica EV. High-intensity interval training or continuous training, combined or not with fasting, in obese or overweight women with cardiometabolic risk factors: study protocol for a randomised clinical trial. BMJ Open. 2018 Apr 28;8(4):e019304. doi: 10.1136/bmjopen-2017-019304.
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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.
EDUARDO V TIBIRICA, MD, PhD principal investigator
National Innstitute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval exercise training in the fed state, Continous exercise training in the fed state and High-intensity interval exercise training in the fasting state in people with Obesity and Overweight, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Mar 2019. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Capillary density (time frame: 6 months). 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 NCT03236285, 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 13 Mar 2019.