OverweightMATISSENCT03357016
HIIT Versus MICT on Abdominal Fat Mass and Lipid Oxidation in Postmenopausal Women (MATISSE)
A study testing Training programs in people with Overweight and Post Menopausal Women, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
Trial summary
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Abdominal fat mass accumulation is associated with an increase of cardiovascular disease (CVD) risk. Read more about this study
- Who is it for?
- Ages 55 to 82 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Post Menopausal Women
- What is being tested?
- Training programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 8 Jun 2018
- 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 55 to 82 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (55- 82 years)
- BMI ≥ 25 and < 40
- Able to follow an exercise protocol
- Eating behavior and physical activity stable since at least 3 month
Who cannot join
- Subject not able to perform exercise after medical examination
- Subject not able to perform bicycle exercise (pains)
- Chronic infection
- Use of β-blocker
- Medical treatment that could interfere with the different outcome measures
- Hormonal Replacement Therapy (HRT)
- Regular consumption of alcohol
- Refusal to sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Abdominal Fat Mass and Energy Substrates Utilization in Postmenopausal Women
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Abdominal fat mass accumulation is associated with an increase of cardiovascular disease (CVD) risk.
Most exercise programs designed for weight loss have focused on about 30 min several times per week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat loss. Accumulating evidence suggests that high intensity interval training (HIIT) should be an effective exercise protocol for reducing body fat of overweight individuals, especially at the abdominal level.
Read more
Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscles groups. Thus, RT seems to be an interesting strategy to fight against deconditioning and autonomy loss with age. Development of muscle mass enhances resting metabolism rate. Thus, RT could raise daily energy expenditure ie. substrates' oxidation including lipids.
The aim of our study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) program combined or not with a resistance training (RT) program on total abdominal and visceral fat mass and substrate utilization in postmenopausal women.
It is hypothesized that HIIT compared to MICT program would result in significantly greater whole body and regional fat mass losses (abdominal and visceral) and would improve lipid oxidation at rest and during prolonged moderate exercise. It is also hypothesized that HIIT associated with RT could be the best strategy to reduce fat mass.
Read the detailed description
Overweight and obesity are dramatically spreading worldwide, and these trends are occurring in both developed and developing countries. Fat mass and more particularly abdominal fat mass is related to the development of cardio-vascular diseases (CVD). Postmenopausal women, as men, are more prone to central or android obesity.
Most exercise programs designed for weight loss have focused on about 30 min several times a week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat losses. Accumulating evidence suggests that high intensity interval training (HIIT) could be an effective exercise protocol for reducing adipose tissue of overweight individuals, especially at the abdominal level. HIIT involves brief high-intensity, anaerobic exercise followed by brief but slightly longer bouts of very low-intensity exercise.
Resistance training (RT) program are currently proposed in order to reduce fat mass / preserve fat-free mass. Their beneficial effects have been demonstrated, especially in the elderly. Through development (or maintenance) of muscle mass, RT increases resting metabolism rate, daily energy expenditure, and substrate (fatty acids) oxidation.
The aim of the study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) combined or not with resistance training (RT) program on total, abdominal and visceral fat mass and substrate utilization at rest and during exercise in postmenopausal women.
36 postmenopausal women will be randomly assigned to MICT (n= 12) or HIIT (n= 12) or HIIT + RT (n= 12) group. Subjects performed three sessions per week during 12 weeks, on bicycle.
MICT: For the MICT protocol, each subject performed 35 min at 50% maximal aerobic power (MAP).
HIIT: For the HIIT protocol, each subject performed repeated cycles of sprinting for 8 s and pedaling slowly for 12 s (between 20 and 30 rpm) for a maximum of 60 repeats per session.
HIIT+RT: For the HIIT+RT protocol, each subject performed HIIT protocol. Then they performed a single set of 8 exercises with 1 or 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition (MR).
Total body and regional fat content will be measured using dual-energy x-ray absorptiometry (DEXA) before and after the intervention (3 months).
The investigators will examine the effects of HIIT, MICT and HIIT + RT programs on:
- Total fat mass (and appendicular fat mass) (DEXA)
- Total fat free mass (and appendicular fat free mass) (DEXA)
- Glycemic profile (plasma HbA1c, plasma glucose)
- Lipid profile (TG, HDL, LDL, total cholesterol)
- Substrates oxidation at rest and during moderate exercise (40min, 50% of maximal oxygen consumption VO2 max)
Statistical analysis
Appropriate sample size has been calculated given previous results about fat mass loss during HIIT in women and considering the dropouts observed in this type of protocol.
Gaussian distribution of the data will be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Mann \& Whitney U test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using Statistica software.
- Conditions
- Overweight, Post Menopausal Women
- Being tested
- Training programs
- Keywords
- interval training, abdominal fat mass, postmenopausal women, lipids oxidation
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programsOther
High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training program (HIIT) | Experimental | Subjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle. Receives: Other: Training programs |
| Moderate Intensity Continuous Training program (MICT) | Experimental | Subjects perform three sessions of training during 12 weeks: repeated cycles of sprinting for 8s and pedaling slowly for 12s (between 20 and 30 rpm) for a maximum of 60 repeats per session. Receives: Other: Training programs |
| HIIT + Resistance Training program (RT) | Experimental | Subjects perform three sessions of training during 12 weeks: Each subject performed HIIT protocol and then a single set of 8 exercises with 1 ou 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition. Receives: Other: Training programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100)
Total abdominal fat mass will be measured in all patients using DEXA based on the methodology of Martin and Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 3 months of training (T3).
Measured: Baseline T0, 3 months after protocol starting
Secondary outcomes (11)
Lipids oxidation evaluated by gas exchange measurements
Evolution of lipids oxidation at rest and during prolonged moderate intensity (40min, 50% of VO2max) using an automated gas analysis system. Carbon dioxide (CO2) production and oxygen consumption (CO2) are expressed in L/min. Respiratory exchange ratio is the ratio between CO2 production and O2 consumption (RER = VCO2/VO2).
Measured: 1 week, 3 months after protocol starting
Visceral fat mass
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Measured: Baseline T0, 3 months after protocol starting
Total fat mass
Change from baseline in total fat mass (g) (determined from DEXA)
Measured: Baseline T0, 3 months after protocol starting
Fat-free mass
Change from baseline in total fat-free mass (g) (determined from DEXA)
Measured: Baseline T0, 3 months after protocol starting
Plasma HbA1c
Change from baseline in plasma HbA1c
Measured: Baseline T0, 3 months after protocol starting
Glucose level
Change from baseline in plasma glucose measurement
Measured: Baseline T0, 3 months after protocol starting
Plasma triglycerides
Change from baseline in plasma triglycerides
Measured: Baseline T0, 3 months after protocol starting
Plasma total cholesterol
Change from baseline in total cholesterol
Measured: Baseline T0, 3 months after protocol starting
Plasma HDL-cholesterol
Change from baseline in HDL-cholesterol
Measured: Baseline T0, 3 months after protocol starting
Plasma LDL-cholesterol
Change from baseline in LDL-cholesterol
Measured: Baseline T0, 3 months after protocol starting
Insulin level
Change from baseline in plasma insulin measurement
Measured: Baseline T0, 3 months after protocol starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Feb 2017
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 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 Vichy Auvergne, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Pr, Principal investigator, CHRU Gabriel Montpied Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357016
- Sponsor's protocol ID
- AU1303
- Other IDs
- 2016-A01742-49
- Acronym
- MATISSE
- Status last verified
- Dec 2017
- First submitted
- 13 Nov 2017
- Last updated
- 10 Aug 2018
- 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 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Abdominal Fat Mass and Energy Substrates Utilization in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03357016
- Acronym / sponsor ID
- MATISSE / AU1303
- Conditions
- Overweight, Post Menopausal Women
- Keywords
- interval training, abdominal fat mass, postmenopausal women, lipids oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Collaborators
- CREPS Vichy Auvergne, University Hospital, Clermont-Ferrand
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 29 Nov 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.
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Abdominal fat mass accumulation is associated with an increase of cardiovascular disease (CVD) risk.
Most exercise programs designed for weight loss have focused on about 30 min several times per week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat loss. Accumulating evidence suggests that high intensity interval training (HIIT) should be an effective exercise protocol for reducing body fat of overweight individuals, especially at the abdominal level.
Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscles groups. Thus, RT seems to be an interesting strategy to fight against deconditioning and autonomy loss with age. Development of muscle mass enhances resting metabolism rate. Thus, RT could raise daily energy expenditure ie. substrates' oxidation including lipids.
The aim of our study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) program combined or not with a resistance training (RT) program on total abdominal and visceral fat mass and substrate utilization in postmenopausal women.
It is hypothesized that HIIT compared to MICT program would result in significantly greater whole body and regional fat mass losses (abdominal and visceral) and would improve lipid oxidation at rest and during prolonged moderate exercise. It is also hypothesized that HIIT associated with RT could be the best strategy to reduce fat mass.
Detailed description
Overweight and obesity are dramatically spreading worldwide, and these trends are occurring in both developed and developing countries. Fat mass and more particularly abdominal fat mass is related to the development of cardio-vascular diseases (CVD). Postmenopausal women, as men, are more prone to central or android obesity.
Most exercise programs designed for weight loss have focused on about 30 min several times a week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat losses. Accumulating evidence suggests that high intensity interval training (HIIT) could be an effective exercise protocol for reducing adipose tissue of overweight individuals, especially at the abdominal level. HIIT involves brief high-intensity, anaerobic exercise followed by brief but slightly longer bouts of very low-intensity exercise.
Resistance training (RT) program are currently proposed in order to reduce fat mass / preserve fat-free mass. Their beneficial effects have been demonstrated, especially in the elderly. Through development (or maintenance) of muscle mass, RT increases resting metabolism rate, daily energy expenditure, and substrate (fatty acids) oxidation.
The aim of the study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) combined or not with resistance training (RT) program on total, abdominal and visceral fat mass and substrate utilization at rest and during exercise in postmenopausal women.
36 postmenopausal women will be randomly assigned to MICT (n= 12) or HIIT (n= 12) or HIIT + RT (n= 12) group. Subjects performed three sessions per week during 12 weeks, on bicycle.
MICT: For the MICT protocol, each subject performed 35 min at 50% maximal aerobic power (MAP).
HIIT: For the HIIT protocol, each subject performed repeated cycles of sprinting for 8 s and pedaling slowly for 12 s (between 20 and 30 rpm) for a maximum of 60 repeats per session.
HIIT+RT: For the HIIT+RT protocol, each subject performed HIIT protocol. Then they performed a single set of 8 exercises with 1 or 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition (MR).
Total body and regional fat content will be measured using dual-energy x-ray absorptiometry (DEXA) before and after the intervention (3 months).
The investigators will examine the effects of HIIT, MICT and HIIT + RT programs on:
- Total fat mass (and appendicular fat mass) (DEXA)
- Total fat free mass (and appendicular fat free mass) (DEXA)
- Glycemic profile (plasma HbA1c, plasma glucose)
- Lipid profile (TG, HDL, LDL, total cholesterol)
- Substrates oxidation at rest and during moderate exercise (40min, 50% of maximal oxygen consumption VO2 max)
Statistical analysis
Appropriate sample size has been calculated given previous results about fat mass loss during HIIT in women and considering the dropouts observed in this type of protocol.
Gaussian distribution of the data will be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Mann \& Whitney U test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using Statistica software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training program (HIIT) | Experimental | Other: Training programsSubjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle. |
| Moderate Intensity Continuous Training program (MICT) | Experimental | Other: Training programsSubjects perform three sessions of training during 12 weeks: repeated cycles of sprinting for 8s and pedaling slowly for 12s (between 20 and 30 rpm) for a maximum of 60 repeats per session. |
| HIIT + Resistance Training program (RT) | Experimental | Other: Training programsSubjects perform three sessions of training during 12 weeks: Each subject performed HIIT protocol and then a single set of 8 exercises with 1 ou 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition. |
Who may qualify
- Ages
- 55 to 82 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (55- 82 years)
- BMI ≥ 25 and < 40
- Able to follow an exercise protocol
- Eating behavior and physical activity stable since at least 3 month
Key exclusion criteria (8 listed)
- Subject not able to perform exercise after medical examination
- Subject not able to perform bicycle exercise (pains)
- Chronic infection
- Use of β-blocker
- Medical treatment that could interfere with the different outcome measures
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 |
|---|---|---|
| Training programsHigh Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT) | Other | HIIT + Resistance Training program (RT), High Intensity Interval Training program (HIIT), Moderate Intensity Continuous Training program (MICT) |
Primary outcome
Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100)
Time frame: Baseline T0, 3 months after protocol starting
Total abdominal fat mass will be measured in all patients using DEXA based on the methodology of Martin and Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 3 months of training (T3).
11 secondary outcomes
Lipids oxidation evaluated by gas exchange measurements
Time frame: 1 week, 3 months after protocol starting
Visceral fat mass
Time frame: Baseline T0, 3 months after protocol starting
Total fat mass
Time frame: Baseline T0, 3 months after protocol starting
Fat-free mass
Time frame: Baseline T0, 3 months after protocol starting
Plasma HbA1c
Time frame: Baseline T0, 3 months after protocol starting
Glucose level
Time frame: Baseline T0, 3 months after protocol starting
Plasma triglycerides
Time frame: Baseline T0, 3 months after protocol starting
Plasma total cholesterol
Time frame: Baseline T0, 3 months after protocol starting
Plasma HDL-cholesterol
Time frame: Baseline T0, 3 months after protocol starting
Plasma LDL-cholesterol
Time frame: Baseline T0, 3 months after protocol starting
Insulin level
Time frame: Baseline T0, 3 months after protocol starting
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 10 Aug 2018.
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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.
Martine Duclos, Pr principal investigator
CHRU Gabriel Montpied Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training programs in people with Overweight and Post Menopausal Women, 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 4 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: finished, as of the sponsor's last update on 10 Aug 2018. 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?
Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100) (time frame: Baseline T0, 3 months after protocol starting). 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 10 Aug 2018.