Clinical trial NCT03940924: HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)
Official title: Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Postmenopausal Women
Keywords: Interval Training
Resistance Training
Overweight
Postmenopausal women
Body composition
Gut microbiota
Lead sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Sponsor class: OTHER
Collaborators: name: CREPS Auvergne Rhône-Alpes (AURA)
First posted: 2019-05-07
Enrollment: 17
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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)

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* BMI ≥ 25 and \< 40
* Able to follow an exercise protocol
* Eating behavior and physical activity stable since at least 3 month

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Changes in the composition of gut microbiota
timeFrame: Baseline T0 and 3 months after intervention starting
Secondary outcomes:
measure: Total fat mass
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Total fat free mass
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Abdominal fat mass
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Visceral fat mass
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Concentration of Short Chain Fatty Acids (SCFAs)
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of fasting glucose level
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of insulinemia
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of HbA1c
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of lipid profile
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of plasma inflammatory marker
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of fitness level
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of muscular capacity
timeFrame: Baseline T0 and 3 months after intervention starting
measure: Evolution of muscular capacity
timeFrame: Baseline T0 and 3 months after intervention starting
Other outcomes:
Locations:
city: Bellerive-sur-Allier
country: France
facility: CREPS Auvergne Rhône-Alpes / Vichy
state: Allier
Study officials:
affiliation: CREPS Auvergne Rhône-Alpes / Vichy
name: Claire MOREL, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.