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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940924

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted September 1, 2020

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.

  • Condition or Disease:Overweight
    Postmenopausal Women
  • Intervention/Treatment: Other: Training program
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Prevention
  • Official Title: Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
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)
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 50 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
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)

Contacts and Locations
Contacts

Contact: Nathalie BOISSEAU, Pr 0473405519 ext +33 Nathalie.boisseau@uca.fr

Locations

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

Sponsors and Collaborators

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

CREPS Auvergne Rhône-Alpes / Vichy

Centre Hospitalier Jacques Lacarin, Vichy

Investigators

Principal Investigator: Claire MOREL, Dr CREPS Auvergne Rhône-Alpes / Vichy

More Information
  • Responsible Party: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
  • ClinicalTrials.gov Identifier: NCT03940924 History of Changes
  • Other Study ID Numbers: 2018-A03230-55
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: September 1, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: Body composition
    Gut microbiota
    Interval Training
    Resistance Training
    Overweight
    Postmenopausal women
  • Additional relevant MeSH terms: Overweight