Overweight and ObesityBIKERUNNCT06082310
Biking vs. Running: Comparison of EPOC, Substrate Oxidation, Appetite and Energy Intakes in Men With Overweight/Obesity.
A study testing Exercise in people with Overweight and Obesity, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
Trial summary
The management of obesity involves hygienic and dietary measures that include appropriate nutrition and an increase in physical activity (PA). Among the various PA modalities that can be recommended, High-Intensity Interval Training (HIIT) is now recognized as a fun and effective program for promoting fat loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2023to 8 Dec 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men with overweight or obesity (BMI between 25 kg/m2 and 35 kg/m2)
Who cannot join
- medical contraindications to intense physical activity,
- painful joints,
- taking ß-blocker
Trial locations and contacts
1 site in 1 country.
France1 site
CREPS Auvergne Rhône-Alpes / Vichy
Bellerive-sur-Allier, Allier, 03321
About this study
Official title: Biking vs. Running HIIT in Men With Overweight/Obesity: Impact on Oxygen Consumption, Substrate Utilization and Appetite
The management of obesity involves hygienic and dietary measures that include appropriate nutrition and an increase in physical activity (PA). Among the various PA modalities that can be recommended, High-Intensity Interval Training (HIIT) is now recognized as a fun and effective program for promoting fat loss. A meta-analysis conducted by our team suggests a potential influence of the mode of HIIT practice (cycling vs. running) on fat mass (FM) loss. In order to better understand the metabolic adaptations following this type of practice, the investigators propose to compare two isoenergetic HIIT sessions (cycling vs. running) in overweight or obese subjects. The objective is to compare post-recovery (+2h) oxygen consumption, substrate utilization, concurrent energy expenditure and post 24h energy intakes.
Read the detailed description
Overweight/obesity, and more specifically intra-abdominal fat mass (FM), are strongly correlated with the development of cardiovascular diseases. High-Intensity Interval Training (HIIT) has emerged as an effective strategy for reducing this detrimental FM. In 2016, AME2P laboratory was the first to demonstrate that HIIT training is more effective than continuous moderate-intensity training (MICT) in promoting the loss of intra-abdominal fat in postmenopausal women. A meta-analysis conducted by AME2P laboratory in 2018, including 39 scientific articles with 617 subjects, confirms the significant effects of HIIT on total and intra-abdominal fat loss in overweight or obese individuals . In addition to the tested modality (HIIT vs. MICT), it seems that the mode of locomotion (HIIT running vs. cycling) may impact body composition differently, with running being more effective for intra-abdominal fat loss and cycling for total FM loss. Cycling primarily involves concentric effort of the lower limbs, while running engages the lower limbs, trunk, and to a lesser extent, the upper limbs, involving both concentric and eccentric muscle contractions. These physiological/biomechanical differences have an impact on metabolic adaptations to exercise and recovery. Thus, at the same relative intensity during continuous exercise, oxygen consumption and energy expenditure are higher in running compared to cycling. Following exercises of intensity greater than 50% of VO2max, excess post-exercise oxygen consumption (EPOC) and lipid oxidation are higher in running compared to cycling. The greater muscle involvement (engaged muscle mass) and the eccentric nature of running (causing muscle damage) are likely responsible for these adaptations.
To better understand changes in body composition following HIIT training in running versus cycling among overweight or obese patients, the investigators propose to compare two isoenergetic HIIT sessions. The objective is to compare post-exercise (+2h) oxygen consumption and substrate utilization. Considering the influence of practice modalities on dietary compensations, the investigators will simultaneously measure spontaneous dietary intakes over the following 24 hours.
Objectives
The main objective is to compare two isoenergetic HIIT sessions: running vs. cycling.
The two tested modalities are as follows:
- HIIT RUN: 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a treadmill speed equivalent to 40% of HRmax].
- HIIT BIKE: 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a power equivalent to 40% of HRmax].
The theoretical maximum heart rate (HRmax) is calculated according to the formula of Gellish et al. (2007): HRmax = 207 - 0.7 x age.
The sessions are conducted in a random order. The second session is adapted (9-12 repetitions) to obtain isoenergetic exercises.
Through these modalities, the investigators will compare post-exercise oxygen consumption (during 2 hours) and carbohydrate and lipid oxidation during the exercise, the recovery period (during 2 hours) (MetaMax 3B Cortex, France), and the appetite 24hours post-exercise (from questionaniers and interview).
*Note that medical supervision of all participants is provided by the Health Department of the CREPS Auvergne-Rhône-Alpes in Vichy, which is authorized for such care. Physicians and physical activity professors are present on site.
General Hypotheses
The investigators propose the following hypotheses:
- Post-exercise oxygen consumption (2 hours) will be higher in HIIT running compared to cycling
- Higher post-exercise oxygen consumption following HIIT running could lead to an increase of lipid utilization during the recovery period.
- Energy intake over 24 hours will not differ due to the isoenergetic nature of the sessions.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise
- Keywords
- Modalities, High-intensity interval exercise, Substrate oxidation, Appetite, Energy Intakes, Enjoyment
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Two HIIT modalities
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training - Biking (HIITBIKE) | Experimental | Cycling exercise: 5 min warm-up + 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a power equivalent to 40% of HRmax]. Receives: Other: Exercise |
| High Intensity Interval Training - Running (HIITRUN) | Experimental | Running exercise: 5 min warm-up + 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a treadmill speed equivalent to 40% of HRmax]. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption during the recovery period
Determination of oxygen consumption 2 hours after the exercise session (cycling and running). Determination from Metamax (3D Cortex).
Measured: Two hours after the end of the exercise
Secondary outcomes (2)
Lipid and carbohydrate oxidation during and after the exercise session (cycling and running).
Determination of lipid and carbohydrate oxidation during and after the exercise (HIIT cycling and running). Lipid and carbohydrate oxidation are measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).
Measured: Measurement during exercise and two hours after the end of the exercise
Energy intakes 24 hours after the exercise
evaluation of energy intakes after the exercise session (cycling vs running) during 24 hours (from questionnaires and interview)
Measured: 24 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start11 Jan 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Sponsor type
- University, hospital or other
- Collaborators
- CREPS Auvergne-Rhône-Alpes de Vichy
- Responsible party
- Sponsor
- Investigators
- Claire Morel, Dr, Principal investigator, CREPS Auvergne Rhône-Alpes / Vichy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082310
- Sponsor's protocol ID
- IRB00012476-2022-22-09-199
- Acronym
- BIKERUN
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biking vs. Running HIIT in Men With Overweight/Obesity: Impact on Oxygen Consumption, Substrate Utilization and Appetite
- ClinicalTrials.gov ID
- NCT06082310
- Acronym / sponsor ID
- BIKERUN / IRB00012476-2022-22-09-199
- Conditions
- Overweight and Obesity
- Keywords
- Modalities, High-intensity interval exercise, Substrate oxidation, Appetite, Energy Intakes, Enjoyment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Collaborators
- CREPS Auvergne-Rhône-Alpes de Vichy
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 13 Oct 2023 (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 management of obesity involves hygienic and dietary measures that include appropriate nutrition and an increase in physical activity (PA). Among the various PA modalities that can be recommended, High-Intensity Interval Training (HIIT) is now recognized as a fun and effective program for promoting fat loss. A meta-analysis conducted by our team suggests a potential influence of the mode of HIIT practice (cycling vs. running) on fat mass (FM) loss. In order to better understand the metabolic adaptations following this type of practice, the investigators propose to compare two isoenergetic HIIT sessions (cycling vs. running) in overweight or obese subjects. The objective is to compare post-recovery (+2h) oxygen consumption, substrate utilization, concurrent energy expenditure and post 24h energy intakes.
Detailed description
Overweight/obesity, and more specifically intra-abdominal fat mass (FM), are strongly correlated with the development of cardiovascular diseases. High-Intensity Interval Training (HIIT) has emerged as an effective strategy for reducing this detrimental FM. In 2016, AME2P laboratory was the first to demonstrate that HIIT training is more effective than continuous moderate-intensity training (MICT) in promoting the loss of intra-abdominal fat in postmenopausal women. A meta-analysis conducted by AME2P laboratory in 2018, including 39 scientific articles with 617 subjects, confirms the significant effects of HIIT on total and intra-abdominal fat loss in overweight or obese individuals . In addition to the tested modality (HIIT vs. MICT), it seems that the mode of locomotion (HIIT running vs. cycling) may impact body composition differently, with running being more effective for intra-abdominal fat loss and cycling for total FM loss. Cycling primarily involves concentric effort of the lower limbs, while running engages the lower limbs, trunk, and to a lesser extent, the upper limbs, involving both concentric and eccentric muscle contractions. These physiological/biomechanical differences have an impact on metabolic adaptations to exercise and recovery. Thus, at the same relative intensity during continuous exercise, oxygen consumption and energy expenditure are higher in running compared to cycling. Following exercises of intensity greater than 50% of VO2max, excess post-exercise oxygen consumption (EPOC) and lipid oxidation are higher in running compared to cycling. The greater muscle involvement (engaged muscle mass) and the eccentric nature of running (causing muscle damage) are likely responsible for these adaptations.
To better understand changes in body composition following HIIT training in running versus cycling among overweight or obese patients, the investigators propose to compare two isoenergetic HIIT sessions. The objective is to compare post-exercise (+2h) oxygen consumption and substrate utilization. Considering the influence of practice modalities on dietary compensations, the investigators will simultaneously measure spontaneous dietary intakes over the following 24 hours.
Objectives
The main objective is to compare two isoenergetic HIIT sessions: running vs. cycling.
The two tested modalities are as follows:
- HIIT RUN: 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a treadmill speed equivalent to 40% of HRmax].
- HIIT BIKE: 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a power equivalent to 40% of HRmax].
The theoretical maximum heart rate (HRmax) is calculated according to the formula of Gellish et al. (2007): HRmax = 207 - 0.7 x age.
The sessions are conducted in a random order. The second session is adapted (9-12 repetitions) to obtain isoenergetic exercises.
Through these modalities, the investigators will compare post-exercise oxygen consumption (during 2 hours) and carbohydrate and lipid oxidation during the exercise, the recovery period (during 2 hours) (MetaMax 3B Cortex, France), and the appetite 24hours post-exercise (from questionaniers and interview).
*Note that medical supervision of all participants is provided by the Health Department of the CREPS Auvergne-Rhône-Alpes in Vichy, which is authorized for such care. Physicians and physical activity professors are present on site.
General Hypotheses
The investigators propose the following hypotheses:
- Post-exercise oxygen consumption (2 hours) will be higher in HIIT running compared to cycling
- Higher post-exercise oxygen consumption following HIIT running could lead to an increase of lipid utilization during the recovery period.
- Energy intake over 24 hours will not differ due to the isoenergetic nature of the sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training - Biking (HIITBIKE) | Experimental | Other: ExerciseCycling exercise: 5 min warm-up + 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a power equivalent to 40% of HRmax]. |
| High Intensity Interval Training - Running (HIITRUN) | Experimental | Other: ExerciseRunning exercise: 5 min warm-up + 9-12 x [45 seconds at 80% of HRmax followed by 1 minute 30 seconds of active recovery at a treadmill speed equivalent to 40% of HRmax]. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men with overweight or obesity (BMI between 25 kg/m2 and 35 kg/m2)
Key exclusion criteria (3 listed)
- medical contraindications to intense physical activity,
- painful joints,
- taking ß-blocker
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 |
|---|---|---|
| ExerciseTwo HIIT modalities | Other | High Intensity Interval Training - Biking (HIITBIKE), High Intensity Interval Training - Running (HIITRUN) |
Primary outcome
oxygen consumption during the recovery period
Time frame: Two hours after the end of the exercise
Determination of oxygen consumption 2 hours after the exercise session (cycling and running). Determination from Metamax (3D Cortex).
2 secondary outcomes
Lipid and carbohydrate oxidation during and after the exercise session (cycling and running).
Time frame: Measurement during exercise and two hours after the end of the exercise
Energy intakes 24 hours after the exercise
Time frame: 24 hours post exercise
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 11 Dec 2023.
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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.
Claire Morel, Dr principal investigator
CREPS Auvergne Rhône-Alpes / Vichy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Overweight and Obesity, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
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 1 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 11 Dec 2023. 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 France. 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?
oxygen consumption during the recovery period (time frame: Two hours after the end of the exercise). 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 11 Dec 2023.