NCT03940924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

May 2, 2019

Last Update Submit

March 16, 2022

Conditions

OverweightPostmenopausal Women

Keywords

Interval TrainingResistance TrainingOverweightPostmenopausal womenBody compositionGut microbiota

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Total fat mass

    Baseline T0 and 3 months after intervention starting

  • Total fat free mass

    Baseline T0 and 3 months after intervention starting

  • Abdominal fat mass

    Baseline T0 and 3 months after intervention starting

  • Visceral fat mass

    Baseline T0 and 3 months after intervention starting

  • Concentration of Short Chain Fatty Acids (SCFAs)

    Baseline T0 and 3 months after intervention starting

  • +8 more secondary outcomes

Study Arms (2)

High Intensity Interval Training (HIIT) + Resistance Training

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Subjects don't have training program. They keep their life style.

Interventions

Training programOTHER

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

High Intensity Interval Training (HIIT) + Resistance Training

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • BMI ≥ 25 and \< 40
  • Able to follow an exercise protocol
  • Eating behavior and physical activity stable since at least 3 month

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CREPS Auvergne Rhône-Alpes / Vichy

Bellerive-sur-Allier, Allier, 03321, France

Location

Related Publications (1)

  • 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.

    PMID: 34628447DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claire MOREL, Dr

    CREPS Auvergne Rhône-Alpes / Vichy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data collected on the volunteers will be made anonymous.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 7, 2019

Study Start

March 1, 2019

Primary Completion

June 30, 2020

Study Completion

December 1, 2020

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

FR(1)