HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)

Study Overview
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Brief Summary
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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
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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)

Official Title
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Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women

Conditions
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Overweight, Postmenopausal Women

Intervention / Treatment
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* Other: Training program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training (HIIT) + Resistance Training<br>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) | Other: Training program<br>* High Intensity Interval Training + Resistance Training (HIIT + RT)<br>|
| No Intervention: Control Group<br>Subjects don't have training program. They keep their life style. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the composition of gut microbiota | Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention. | Baseline T0 and 3 months after intervention starting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fat mass | Change from baseline in total fat mass (g) (estimated from DEXA) | Baseline T0 and 3 months after intervention starting | 
| Total fat free mass | Change from baseline in total fat free mass (g) (estimated from DEXA) | Baseline T0 and 3 months after intervention starting | 
| Abdominal fat mass | Change from baseline in abdominal fat mass (g) (estimated from DEXA) | Baseline T0 and 3 months after intervention starting | 
| Visceral fat mass | Change from baseline in visceral fat mass (g) (estimated from DEXA) | 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 | Baseline T0 and 3 months after intervention starting | 
| Evolution of fasting glucose level | Change from baseline in plasma fasting glucose level | Baseline T0 and 3 months after intervention starting | 
| Evolution of insulinemia | Change from baseline in plasma fasting insulinemia (mmol/L) | Baseline T0 and 3 months after intervention starting | 
| Evolution of HbA1c | Change from baseline in plasma HbA1c (%) | Baseline T0 and 3 months after intervention starting | 
| Evolution of lipid profile | Change from baseline in plasma triglycerides, total cholesterol, LDL- and HDL cholesterol. | Baseline T0 and 3 months after intervention starting | 
| Evolution of plasma inflammatory marker | Change from baseline in plasma C-Reactive Protein | Baseline T0 and 3 months after intervention starting | 
| Evolution of fitness level | Change from baseline in VO2max | Baseline T0 and 3 months after intervention starting | 
| Evolution of muscular capacity | Change from baseline maximal isometric strenght | Baseline T0 and 3 months after intervention starting | 
| Evolution of muscular capacity | Change from baseline maximal dynamic strenght | Baseline T0 and 3 months after intervention starting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interval Training, Resistance Training, Overweight, Postmenopausal women, Body composition, Gut microbiota