OverweightPACWOManNCT03940924
HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)
A study testing Training program in people with Overweight and Postmenopausal 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. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Postmenopausal Women
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Dec 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 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- 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)
- Use of β-blocker
- Medical treatment that could interfere with the different outcome measures (antibiotics)
- Hormonal Replacement Therapy (HRT)
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 High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Moreover, abdominal fat mass accumulation is associated with an increase of cardiovascular disease risks.
Recent studies suggest that physical activity may positively alter gut microbiota composition. Accumulating evidence suggests that high intensity interval training (HIIT) is an effective strategy 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 muscle groups. Thus, RT is also an interesting modality to fight against deconditioning and autonomy loss with age.
Read more
The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.
It is hypothesized that HIIT +RT will improve gut microbiota and body composition (including whole body and (intra)-abdominal fat mass) in a concomitant and parallel way.
Read the detailed description
The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.
30 postmenopausal women will be randomly assigned to HIIT + RT (n= 15) group or Control group (n=15).
HIIT+RT: Each subject performed HIIT protocol consisted of repeated 60 cycles of speeding up for 8 s followed by pedalling slowly for 12 s (20min) Then they performed a single set of 10 exercises with 1 or 2min resting period between exercises. The set consisted of 8-12 repetitions at about 80% maximum repetition (1RM).
Control group : (no training program) Subjects will keep their life style.
Faecal microbiota and body composition will be measured before and after the intervention (3 months).
The investigators will examine the effects of HIIT + RT programs on:
Body composition : total-abdominal and visceral fat mass, total fat free mass and muscle mass Faecal concentration of short chain fatty acids Total fat free mass (and appendicular fat free mass) (DEXA) Glycemic profile (plasma HbA1c, plasma glucose, plasma insulin) Lipid profile (TG, HDL, LDL, total cholesterol) Aerobic capacity (VO2 max) Muscular capacity (fatigability, isometric and dynamic strenght)
- Conditions
- Overweight, Postmenopausal Women
- Being tested
- Training program
- Keywords
- Interval Training, Resistance Training, Overweight, Postmenopausal women, Body composition, Gut microbiota
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
High Intensity Interval Training + Resistance Training (HIIT + RT)
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) + Resistance Training | Experimental | Subjects perform three sessions of training during 12 weeks. Session are composed of 20min HIIT program : 60 cycles of speeding up for 8s and pedaling slowly for 12s. (Intensity between 85 and 90% HRmax) + a single set circuits including 10 exercises with a load of 8-12 repetition at around 80% of maximal repetition (1RM) Receives: Other: Training program |
| Control Group | No intervention | Subjects don't have training program. They keep their life style. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the composition of gut microbiota
Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention.
Measured: Baseline T0 and 3 months after intervention starting
Secondary outcomes (13)
Total fat mass
Change from baseline in total fat mass (g) (estimated from DEXA)
Measured: Baseline T0 and 3 months after intervention starting
Total fat free mass
Change from baseline in total fat free mass (g) (estimated from DEXA)
Measured: Baseline T0 and 3 months after intervention starting
Abdominal fat mass
Change from baseline in abdominal fat mass (g) (estimated from DEXA)
Measured: Baseline T0 and 3 months after intervention starting
Visceral fat mass
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Measured: Baseline T0 and 3 months after intervention starting
Concentration of Short Chain Fatty Acids (SCFAs)
Short Chain Fatty Acid's concentration in faeces will be measured
Measured: Baseline T0 and 3 months after intervention starting
Evolution of fasting glucose level
Change from baseline in plasma fasting glucose level
Measured: Baseline T0 and 3 months after intervention starting
Evolution of insulinemia
Change from baseline in plasma fasting insulinemia (mmol/L)
Measured: Baseline T0 and 3 months after intervention starting
Evolution of HbA1c
Change from baseline in plasma HbA1c (%)
Measured: Baseline T0 and 3 months after intervention starting
Evolution of lipid profile
Change from baseline in plasma triglycerides, total cholesterol, LDL- and HDL cholesterol.
Measured: Baseline T0 and 3 months after intervention starting
Evolution of plasma inflammatory marker
Change from baseline in plasma C-Reactive Protein
Measured: Baseline T0 and 3 months after intervention starting
Evolution of fitness level
Change from baseline in VO2max
Measured: Baseline T0 and 3 months after intervention starting
Evolution of muscular capacity
Change from baseline maximal isometric strenght
Measured: Baseline T0 and 3 months after intervention starting
Evolution of muscular capacity
Change from baseline maximal dynamic strenght
Measured: Baseline T0 and 3 months after intervention starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Mar 2019
- Primary completion30 Jun 2020
- Study completion1 Dec 2020
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 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
- 17 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 (AURA)
- Responsible party
- Sponsor
- Investigators
- Claire MOREL, Dr, Principal investigator, CREPS Auvergne Rhône-Alpes / Vichy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940924
- Sponsor's protocol ID
- 2018-A03230-55
- Acronym
- PACWOMan
- Status last verified
- Mar 2022
- First submitted
- 2 May 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dupuit M, Rance M, Morel C, Bouillon P, Boscaro A, Martin V, Vazeille E, Barnich N, Chassaing B, Boisseau N. Effect of Concurrent Training on Body Composition and Gut Microbiota in Postmenopausal Women with Overweight or Obesity. Med Sci Sports Exerc. 2022 Mar 1;54(3):517-529. doi: 10.1249/MSS.0000000000002809.
PubMed 34628447
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03940924
- Acronym / sponsor ID
- PACWOMan / 2018-A03230-55
- Conditions
- Overweight, Postmenopausal Women
- Keywords
- Interval Training, Resistance Training, Overweight, Postmenopausal women, Body composition, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Collaborators
- CREPS Auvergne Rhône-Alpes (AURA)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 7 May 2019 (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. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Moreover, abdominal fat mass accumulation is associated with an increase of cardiovascular disease risks.
Recent studies suggest that physical activity may positively alter gut microbiota composition. Accumulating evidence suggests that high intensity interval training (HIIT) is an effective strategy 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 muscle groups. Thus, RT is also an interesting modality to fight against deconditioning and autonomy loss with age.
The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.
It is hypothesized that HIIT +RT will improve gut microbiota and body composition (including whole body and (intra)-abdominal fat mass) in a concomitant and parallel way.
Detailed description
The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.
30 postmenopausal women will be randomly assigned to HIIT + RT (n= 15) group or Control group (n=15).
HIIT+RT: Each subject performed HIIT protocol consisted of repeated 60 cycles of speeding up for 8 s followed by pedalling slowly for 12 s (20min) Then they performed a single set of 10 exercises with 1 or 2min resting period between exercises. The set consisted of 8-12 repetitions at about 80% maximum repetition (1RM).
Control group : (no training program) Subjects will keep their life style.
Faecal microbiota and body composition will be measured before and after the intervention (3 months).
The investigators will examine the effects of HIIT + RT programs on:
Body composition : total-abdominal and visceral fat mass, total fat free mass and muscle mass Faecal concentration of short chain fatty acids Total fat free mass (and appendicular fat free mass) (DEXA) Glycemic profile (plasma HbA1c, plasma glucose, plasma insulin) Lipid profile (TG, HDL, LDL, total cholesterol) Aerobic capacity (VO2 max) Muscular capacity (fatigability, isometric and dynamic strenght)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) + Resistance Training | Experimental | Other: Training programSubjects perform three sessions of training during 12 weeks. Session are composed of 20min HIIT program : 60 cycles of speeding up for 8s and pedaling slowly for 12s. (Intensity between 85 and 90% HRmax) + a single set circuits including 10 exercises with a load of 8-12 repetition at around 80% of maximal repetition (1RM) |
| Control Group | No intervention | –Subjects don't have training program. They keep their life style. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- BMI ≥ 25 and < 40
- Able to follow an exercise protocol
- Eating behavior and physical activity stable since at least 3 month
Key exclusion criteria (5 listed)
- Subject not able to perform exercise after medical examination
- Subject not able to perform bicycle exercise (pains)
- Use of β-blocker
- Medical treatment that could interfere with the different outcome measures (antibiotics)
- Hormonal Replacement Therapy (HRT)
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 programHigh Intensity Interval Training + Resistance Training (HIIT + RT) | Other | High Intensity Interval Training (HIIT) + Resistance Training |
Primary outcome
Changes in the composition of gut microbiota
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention.
13 secondary outcomes
Total fat mass
Time frame: Baseline T0 and 3 months after intervention starting
Total fat free mass
Time frame: Baseline T0 and 3 months after intervention starting
Abdominal fat mass
Time frame: Baseline T0 and 3 months after intervention starting
Visceral fat mass
Time frame: Baseline T0 and 3 months after intervention starting
Concentration of Short Chain Fatty Acids (SCFAs)
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of fasting glucose level
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of insulinemia
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of HbA1c
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of lipid profile
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of plasma inflammatory marker
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of fitness level
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of muscular capacity
Time frame: Baseline T0 and 3 months after intervention starting
Evolution of muscular capacity
Time frame: Baseline T0 and 3 months after intervention 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 31 Mar 2022.
- Derived from this study: PubMed 34628447Dupuit M, Rance M, Morel C, Bouillon P, Boscaro A, Martin V, Vazeille E, Barnich N, Chassaing B, Boisseau N. Effect of Concurrent Training on Body Composition and Gut Microbiota in Postmenopausal Women with Overweight or Obesity. Med Sci Sports Exerc. 2022 Mar 1;54(3):517-529. doi: 10.1249/MSS.0000000000002809.
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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 Training program in people with Overweight and Postmenopausal 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 5 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 31 Mar 2022. 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?
Changes in the composition of gut microbiota (time frame: Baseline T0 and 3 months after intervention starting). 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 NCT03940924, 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 31 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.