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

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.

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Postmenopausal Women
• Intervention / Treatment: Other: Training program

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Allier
    • Bellerive-sur-Allier, Allier, France, 03321
      • CREPS Auvergne Rhône-Alpes / Vichy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
• Collaborators: CREPS Auvergne Rhône-Alpes (AURA)
• Investigators: Principal Investigator: Claire Morel, Dr, CREPS Auvergne Rhône-Alpes / Vichy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 5, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Overweight; Body composition; Gut microbiota; Resistance Training; Postmenopausal women; Interval Training
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2018-A03230-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No