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Completed

NCT Number: NCT03940924

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Postmenopausal Women Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CREPS Auvergne Rhône-Alpes / Vichy

Bellerive-sur-Allier, Allier, 03321, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Training program

Other

High Intensity Interval Training + Resistance Training (HIIT + RT)

Primary outcomes

  1. Changes in the composition of gut microbiota

    Time frame: Baseline T0 and 3 months after intervention starting

    Evolution of microbiota composition will be evaluated from fecal microbiota analyse before and after intervention.

Secondary outcomes

  1. Total fat mass

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in total fat mass (g) (estimated from DEXA)

  2. Total fat free mass

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in total fat free mass (g) (estimated from DEXA)

  3. Abdominal fat mass

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in abdominal fat mass (g) (estimated from DEXA)

  4. Visceral fat mass

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in visceral fat mass (g) (estimated from DEXA)

  5. Concentration of Short Chain Fatty Acids (SCFAs)

    Time frame: Baseline T0 and 3 months after intervention starting

    Short Chain Fatty Acid's concentration in faeces will be measured

  6. Evolution of fasting glucose level

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in plasma fasting glucose level

  7. Evolution of insulinemia

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in plasma fasting insulinemia (mmol/L)

  8. Evolution of HbA1c

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in plasma HbA1c (%)

  9. Evolution of lipid profile

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in plasma triglycerides, total cholesterol, LDL- and HDL cholesterol.

  10. Evolution of plasma inflammatory marker

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in plasma C-Reactive Protein

  11. Evolution of fitness level

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline in VO2max

  12. Evolution of muscular capacity

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline maximal isometric strenght

  13. Evolution of muscular capacity

    Time frame: Baseline T0 and 3 months after intervention starting

    Change from baseline maximal dynamic strenght

Sponsors and collaborators

Lead sponsor

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

Other

Collaborators

  • CREPS Auvergne Rhône-Alpes (AURA)

Registry information

Official study title

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

Acronym: PACWOMan

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2019
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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