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

Overweight Clinical Trial

— PACWOMan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940924
• Other study ID #: 2018-A03230-55
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2022
• Source: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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 ß-blocker
• Medical treatment that could interfere with the different outcome measures (antibiotics)
• Hormonal Replacement Therapy (HRT)

Related Conditions & MeSH terms

• Overweight
• Postmenopausal Women

Intervention

Other:
• Training program
High Intensity Interval Training + Resistance Training (HIIT + RT)

Locations

Country	Name	City	State
France	CREPS Auvergne Rhône-Alpes / Vichy	Bellerive-sur-Allier	Allier

Sponsors (2)

Lead Sponsor	Collaborator
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques	CREPS Auvergne Rhône-Alpes (AURA)

Country where clinical trial is conducted

France, 

Outcome

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