Overweight and ObesityRIESLINGNCT05311800
High-Intensity Interval Training and Fat Mass Losses
A study testing Physical activity in people with Overweight and Obesity and Men, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
Trial summary
The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (VO2max) and gut… 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, Men
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Jul 2022
- 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 (18 to 65 years old)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 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: Effect of Two Isoenergetic Modes of High-Intensity Interval Training on Total and Abdominal Fat Mass Loss in Men With Overweight or Obesity.
The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with overweight or obesity.
The investigators hypothesized that both programs could decrease total, abdominal and visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and blood flow, and that running could favors greater fat mass losses.
Read the detailed description
The first aim of this study was to compare two isoenergetic HIIT programs (cycling vs. running) on body composition in men with overweight or obesity.
20 men with overweight or obesity should completed HIIT program three times a week during twelve weeks.
- High intensity interval training - BIKE (HIIE BIKE) 10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) ii) High intensity interval training - RUN (HIIE RUN) 9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s)
Body composition will be measured before and after HIIT program by Dual-energy X-ray absorptiometry (DXA).
- Conditions
- Overweight and Obesity, Men
- Being tested
- Physical activity
- Keywords
- cycling, running, high-intensity interval training, fat mass, visceral tissue, health
- Medical subject headings
- Overweight, Obesity, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Comparison of HIIT mode (running vs cycling)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training - BIKE (HIIE BIKE) | Experimental | 10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) Receives: Other: Physical activity |
| High intensity interval training - RUN (HIIE RUN) | Experimental | 9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s) Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIIT mode and fat mass change (g)
change of total fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison
Measured: At the first and the last training - week 1 and 12
HIIT mode and abdominal fat mass change (g)
change of abdominal fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison
Measured: At the first and the last training - week 1 and 12
Secondary outcomes (1)
Rate of carbohydrate and lipid oxidation (g.min-1) during a sub-maximal exercise by measuring gaz exchange.
Carbohydrate and lipid oxidation rate (g.min-1) during a submaximal exercise before and after the HIIT protocol. HIIT mode comparison.
Measured: At the first and the last training - week 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Sep 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups : running vs cycling
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311800
- Sponsor's protocol ID
- ID-RCB 2019-A02999-48
- Acronym
- RIESLING
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Isoenergetic Modes of High-Intensity Interval Training on Total and Abdominal Fat Mass Loss in Men With Overweight or Obesity.
- ClinicalTrials.gov ID
- NCT05311800
- Acronym / sponsor ID
- RIESLING / ID-RCB 2019-A02999-48
- Conditions
- Overweight and Obesity, Men
- Keywords
- cycling, running, high-intensity interval training, fat mass, visceral tissue, health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Apr 2022 (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 aims of this study was to compare two isoenergetic HIIT (High-intensity Interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with overweight or obesity.
The investigators hypothesized that both programs could decrease total, abdominal and visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and blood flow, and that running could favors greater fat mass losses.
Detailed description
The first aim of this study was to compare two isoenergetic HIIT programs (cycling vs. running) on body composition in men with overweight or obesity.
20 men with overweight or obesity should completed HIIT program three times a week during twelve weeks.
- High intensity interval training - BIKE (HIIE BIKE) 10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) ii) High intensity interval training - RUN (HIIE RUN) 9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s)
Body composition will be measured before and after HIIT program by Dual-energy X-ray absorptiometry (DXA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups : running vs cycling
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training - BIKE (HIIE BIKE) | Experimental | Other: Physical activity10 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) |
| High intensity interval training - RUN (HIIE RUN) | Experimental | Other: Physical activity9 cycles of speeding up for 45 s at 80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (35min15s) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men (18 to 65 years old)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 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 |
|---|---|---|
| Physical activityComparison of HIIT mode (running vs cycling) | Other | High intensity interval training - BIKE (HIIE BIKE), High intensity interval training - RUN (HIIE RUN) |
Primary outcome
HIIT mode and fat mass change (g)
Time frame: At the first and the last training - week 1 and 12
change of total fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison
HIIT mode and abdominal fat mass change (g)
Time frame: At the first and the last training - week 1 and 12
change of abdominal fat mass (in grams from DXA analysis) after 3 months of training- HIIT mode comparison
1 secondary outcome
Rate of carbohydrate and lipid oxidation (g.min-1) during a sub-maximal exercise by measuring gaz exchange.
Time frame: At the first and the last training - week 1 and 12
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 24 Feb 2023.
- Individual participant dataSharing planned: No
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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 Physical activity in people with Overweight and Obesity and Men, 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 2 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 24 Feb 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?
HIIT mode and fat mass change (g) (time frame: At the first and the last training - week 1 and 12). The study lists 2 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 24 Feb 2023.