HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan) (PACWOMan)
Primary Purpose
Overweight, Postmenopausal Women
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training program
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Interval Training, Resistance Training, Overweight, Postmenopausal women, Body composition, Gut microbiota
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)
Sites / Locations
- CREPS Auvergne Rhône-Alpes / Vichy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High Intensity Interval Training (HIIT) + Resistance Training
Control Group
Arm Description
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)
Subjects don't have training program. They keep their life style.
Outcomes
Primary Outcome Measures
Changes in the composition of gut microbiota
Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention.
Secondary Outcome Measures
Total fat mass
Change from baseline in total fat mass (g) (estimated from DEXA)
Total fat free mass
Change from baseline in total fat free mass (g) (estimated from DEXA)
Abdominal fat mass
Change from baseline in abdominal fat mass (g) (estimated from DEXA)
Visceral fat mass
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Concentration of Short Chain Fatty Acids (SCFAs)
Short Chain Fatty Acid's concentration in faeces will be measured
Evolution of fasting glucose level
Change from baseline in plasma fasting glucose level
Evolution of insulinemia
Change from baseline in plasma fasting insulinemia (mmol/L)
Evolution of HbA1c
Change from baseline in plasma HbA1c (%)
Evolution of lipid profile
Change from baseline in plasma triglycerides, total cholesterol, LDL- and HDL cholesterol.
Evolution of plasma inflammatory marker
Change from baseline in plasma C-Reactive Protein
Evolution of fitness level
Change from baseline in VO2max
Evolution of muscular capacity
Change from baseline maximal isometric strenght
Evolution of muscular capacity
Change from baseline maximal dynamic strenght
Full Information
NCT ID
NCT03940924
First Posted
May 2, 2019
Last Updated
March 16, 2022
Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Auvergne Rhône-Alpes (AURA)
1. Study Identification
Unique Protocol Identification Number
NCT03940924
Brief Title
HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)
Acronym
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Auvergne Rhône-Alpes (AURA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Postmenopausal Women
Keywords
Interval Training, Resistance Training, Overweight, Postmenopausal women, Body composition, Gut microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Data collected on the volunteers will be made anonymous.
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training (HIIT) + Resistance Training
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects don't have training program. They keep their life style.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
High Intensity Interval Training + Resistance Training (HIIT + RT)
Primary Outcome Measure Information:
Title
Changes in the composition of gut microbiota
Description
Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention.
Time Frame
Baseline T0 and 3 months after intervention starting
Secondary Outcome Measure Information:
Title
Total fat mass
Description
Change from baseline in total fat mass (g) (estimated from DEXA)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Total fat free mass
Description
Change from baseline in total fat free mass (g) (estimated from DEXA)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Abdominal fat mass
Description
Change from baseline in abdominal fat mass (g) (estimated from DEXA)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Visceral fat mass
Description
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Concentration of Short Chain Fatty Acids (SCFAs)
Description
Short Chain Fatty Acid's concentration in faeces will be measured
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of fasting glucose level
Description
Change from baseline in plasma fasting glucose level
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of insulinemia
Description
Change from baseline in plasma fasting insulinemia (mmol/L)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of HbA1c
Description
Change from baseline in plasma HbA1c (%)
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of lipid profile
Description
Change from baseline in plasma triglycerides, total cholesterol, LDL- and HDL cholesterol.
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of plasma inflammatory marker
Description
Change from baseline in plasma C-Reactive Protein
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of fitness level
Description
Change from baseline in VO2max
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of muscular capacity
Description
Change from baseline maximal isometric strenght
Time Frame
Baseline T0 and 3 months after intervention starting
Title
Evolution of muscular capacity
Description
Change from baseline maximal dynamic strenght
Time Frame
Baseline T0 and 3 months after intervention starting
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire MOREL, Dr
Organizational Affiliation
CREPS Auvergne Rhône-Alpes / Vichy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CREPS Auvergne Rhône-Alpes / Vichy
City
Bellerive-sur-Allier
State/Province
Allier
ZIP/Postal Code
03321
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34628447
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.
Results Reference
derived
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HIIT + RT on Body Composition and Gut Microbiota in Postmenopausal Women (PACWOMan)
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